bims-tuinly Biomed News
on Tumor-infiltrating lymphocytes therapy
Issue of 2025–12–07
28 papers selected by
Pierpaolo Ginefra, Ludwig Institute for Cancer Research



  1. Diagn Pathol. 2025 Dec 01.
       BACKGROUND: The prognostic impact of high mobility group box 1 (HMGB1) in lung adenocarcinoma may depend on its subcellular localization, while the density of tumor-infiltrating lymphocytes (TILs) reflects the host anti-tumor immune response. However, the combined prognostic value of these two factors in early-stage lung adenocarcinoma remains unclear.
    METHODS: This retrospective study included 112 patients with pathological stage I-II lung adenocarcinoma who underwent complete surgical resection at our institution between 2007 and 2017. None received neoadjuvant chemotherapy or radiotherapy. Immunohistochemistry was performed on formalin-fixed, paraffin-embedded tumor specimens to evaluate HMGB1 subcellular localization and stromal TILs infiltration. The latter was semi-quantitatively assessed according to the International TILs Working Group recommendations and dichotomized using the median value as the cutoff. Clinicopathological variables, including differentiation, pleural invasion, lymphovascular invasion, and pathological stage, were collected and correlated with HMGB1 localization and TIL status. Survival outcomes were analyzed using Kaplan-Meier and Cox proportional hazards models. Multivariable analyses were adjusted according to the events-per-variable (EPV) rules, and model diagnostics included proportional hazards testing and multicollinearity assessment. Interobserver agreement for HMGB1 localization was evaluated using Fleiss'κ statistics.
    RESULTS: Cytoplasmic HMGB1 expression and low TIL infiltration were significantly associated with adverse clinicopathological features, including poorer differentiation and higher rates of lymphovascular invasion. Both cytoplasmic HMGB1 and low TIL levels independently predicted a shorter DFS and OS. Patients with the combined phenotype of cytoplasmic HMGB1 and low TIL levels had the worst prognosis, with hazard ratios exceeding those of either factor alone. The integrative model based on HMGB1 localization and TIL status enhanced the prognostic discrimination beyond conventional clinicopathological parameters.
    CONCLUSIONS: HMGB1 subcellular localization and TIL infiltration are independent prognostic biomarkers of early-stage lung adenocarcinoma. An integrative model combining these parameters provides enhanced risk stratification and may inform individualized postoperative management strategies.
    Keywords:  High mobility group box 1 (HMGB1); Immunohistochemistry; Integrative model; Lung adenocarcinoma; Prognosis; Tumor-infiltrating lymphocytes (TILs)
    DOI:  https://doi.org/10.1186/s13000-025-01736-w
  2. J Immunother Cancer. 2025 Nov 29. pii: e013420. [Epub ahead of print]13(11):
      Immunity to solid tumors is associated with the hallmarks of cancer-associated inflammation and the ability of immune mechanisms to limit tumor progression. Application of expanded tumor-infiltrating lymphocyte adoptive T cell therapy (TIL ACT) in clinical trials is now practiced at many sites around the world. Prior to immune checkpoint blockade (ICB), an approximate 50% objective response rate was consistently observed across multiple institutions for patients with melanoma. This now-approved strategy approaches 35% in recent studies from the USA and 49% with more highly selected patients in Europe. Here, we focus on early TIL studies in non-melanoma epithelial neoplasms. Increased understanding of cancer immunology has allowed changes in the TIL expansion process to include: (1) initial generation of TIL from fragments, (2) use of specialized large-scale culture vessels, (3) use of the rapid expansion protocol to enable 'young' TIL prosecution, and (4) treatment regimens employing non-myeloablative (NMA) chemotherapy followed by brief interleukin-2 administration. NMA leads to homeostatic proliferation of the transferred T cells, engraftment, profound neutropenia and lymphopenia, and improved clinical outcome. A key success of TIL ACT relies on the quality, specificity, and number of pre-existing TIL. This, in turn, is highly influenced by the suppressive tumor microenvironment. Thus, any means to alter 'cold tumor (non-T cell inflamed)' to 'hot tumor (T cell inflamed)' is theoretically desirable to improve both the quality and quantity of TIL obtained before harvest. Combinations of other immunotherapies such as application of ICB, co-stimulatory molecule agonist antibodies, autophagy inhibition, and dendritic cell support strategies could provide additional- improvements in TIL therapy and enable harnessing of the adaptive immune response to enhance the clinical outcome of TIL-ACT patients.
    Keywords:  Adoptive cell therapy - ACT; Immunotherapy; Tumor infiltrating lymphocyte - TIL; Tumor microenvironment - TME; Tumor mutation burden - TMB
    DOI:  https://doi.org/10.1136/jitc-2025-013420
  3. ACS Nano. 2025 Dec 05.
      Nanomedicine offers promising strategies for targeted drug delivery, imaging, and molecular-level therapies. However, the clinical translation of nanomedicine has often been hindered by the complex interactions of nanoparticles (NPs) with biological systems. This study investigates a cell-based delivery platform designed to overcome some of these limitations, using clinical-grade tumor-infiltrating lymphocytes (TILs) as biological carriers of boron carbide (B4C) NPs in boron neutron capture therapy (BNCT). Biological vectors, such as TILs, could enable selective tumor targeting, leading to highly localized 10B levels and minimizing off-target accumulation. We evaluated the uptake and retention of composite Fe2O3-B4C NPs (FeBNPs) using both immortalized Jurkat T cells and primary human TILs. Both cell types efficiently internalized FeBNPs without cytotoxic effects, maintained their functionalities, and retained the boron-rich NPs for up to 72 h. Imaging confirmed intracellular localization, and neutron autoradiography demonstrated that TILs accumulated sufficient 10B for therapeutic efficacy, eliminating the need for isotopically enriched compounds like L-4-boronophenylalanine (BPA) or sodium borocaptate (BSH). Coculture experiments with Jurkat and HeLa cells confirmed that lymphocyte-delivered boron could mediate localized radiation damage via neutron capture. These findings support the concept of TILs as "Trojan Horses" for boron delivery, allowing for overcoming traditional barriers in NP-based therapies and taking advantage of their innate tumor-homing ability. This approach not only enhances BNCT selectivity and efficacy but also supports the integration of nanomedicine with adoptive cell therapy in a combined cancer treatment framework.
    Keywords:  BNCT; adoptive cell therapy; boron carbide; nanoparticles; tumor-infiltrating lymphocytes
    DOI:  https://doi.org/10.1021/acsnano.5c12640
  4. Front Immunol. 2025 ;16 1718443
      Tumor-infiltrating lymphocyte (TIL) therapy has demonstrated efficacy for the treatment of immune checkpoint therapy-resistant/refractory advanced melanoma patients. However, its safety and efficacy remain to be determined among patients with concurrent chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and advanced melanoma. This case is the first to demonstrate the successful treatment of a metastatic melanoma patient with concurrent CLL/SLL using lymphodepleting chemotherapy followed by unselected TIL and interleukin-2. The treatment was safe with no new toxicities observed, resulting in a durable radiological partial response and molecular response with the complete clearance of detectable circulating tumor DNA. The microenvironment of the harvested melanoma used to generate the TIL product contained an abundance of CD8+TCF1+ and CD8+CD69+ T cells, spatial co-clustering of CD8+ T cells with CD11c myeloid networks. Despite containing SLL deposits, the harvested melanoma produced a CD8+ T cell-predominant tumor-reactive TIL infusion product containing stem-like CD39negCD69neg CD8+ T cells. A strong overlap (60%) in the TCRβ sequences between this infusion product and peripheral blood mononuclear cells collected at the 9-month follow-up visit was evidence of long-term persistence of TIL in this patient.
    Keywords:  adoptive cell immunotherapy; cell therapy; chronic lymphocytic leukemia/small lymphocytic lymphoma; melanoma; tumor infiltrating lymphocytes
    DOI:  https://doi.org/10.3389/fimmu.2025.1718443
  5. BMC Cancer. 2025 Dec 05. 25(1): 1856
      
    Keywords:  Immunotherapy biomarkers.; Neoadjuvant chemotherapy; Residual disease; Triple-negative breast cancer; Tumor-infiltrating lymphocytes
    DOI:  https://doi.org/10.1186/s12885-025-15207-4
  6. JNCI Cancer Spectr. 2025 Dec 04. pii: pkaf114. [Epub ahead of print]
       BACKGROUND: Deficient mismatch repair (dMMR) and microsatellite instability-high (MSI-H) tumors constitute approximately 15% of localized colorectal cancers (CRC). Prognostic biomarkers such as tumor-infiltrating lymphocytes (TILs) and BRAF and KRAS mutations may guide personalized treatment for these patients, and this systematic review and meta-analysis aimed to evaluate their impact on survival outcomes.
    METHODS: Literature searches were conducted across PubMed, Embase, Cochrane Library, and Web of Science, including studies published between 2004 and 2023. The primary outcomes were overall survival (OS), disease-free survival (DFS), and cancer-specific survival (CSS). The risk of bias was assessed using the Newcastle-Ottawa Scale, and the certainty of evidence using the GRADE approach.
    RESULTS: The literature search yielded 5636 articles. 54 studies were included in the systematic review and 31 studies in the meta-analysis, totaling 4551 patients. High TIL density was significantly associated with improved OS (HR = 0.39; 95% CI: 0.17-0.89) and DFS (HR = 0.45; 95% CI: 0.29-0.71). BRAF and KRAS mutations were seen in 52% and 34% of patients, respectively, and were associated with poorer OS (HR = 1.43; 95% CI: 1.13-1.80 and HR = 1.30; 95% CI: 1.09-1.54, respectively). Quality of evidence was moderate to high across all exposures and outcomes.
    CONCLUSION: High infiltration of TILs correlated with improved OS and DFS, whereas BRAF and KRAS mutations were associated with worse OS in patients with localized dMMR/MSI-H CRC. These findings highlight the potential utility of biomarkers for improving prognostic assessment and personalizing management in dMMR CRC.
    Keywords:  BRAF; KRAS; colorectal cancer; deficient mismatch repair; tumor-infiltrating lymphocytes
    DOI:  https://doi.org/10.1093/jncics/pkaf114
  7. bioRxiv. 2025 Nov 20. pii: 2025.11.19.689204. [Epub ahead of print]
      Tumor-infiltrating lymphocyte (TIL) therapy is FDA-approved for patients with treatment-resistant advanced melanoma, but the TIL subpopulations critical for tumor eradication remains incompletely understood. Using patient-derived TIL-melanoma co-cultures, we identified and characterized a novel subset of CD8 + TIL, capable of class I HLA-independent cancer cell lysis. The lymphotoxin β receptor (LTβR) and interferon (IFN) sensing pathways were nominated as key determinants of TIL-mediated cancer cell killing from a whole-genome, loss-of-function CRISPR screen. Validation studies confirmed that dual LTβR and IFN sensing is necessary and sufficient for cancer cell lysis, and that expanded CD8 + TIL express high lymphotoxin β ( LTB ) and upregulate lymphotoxin α ( LTA ) upon coculture with cancer cells. Leveraging paired scRNA-seq and scTCR-seq data, we confirmed that enrichment of LTB + CD8 + T cells is associated with clinical response to TIL, and that LTB + CD8 + TIL are expanded from putative neoantigen-reactive, LTB lo CD8 + T cells in resected tumors.
    Significance: We have uncovered a previously unrecognized mechanism of TIL-mediated tumor eradication, providing mechanistic insights into the role of LTBR/IFN signaling in TIL-mediated cancer cell killing, and potentially offering insights into novel strategies to isolate, enrich, and expand tumoricidal TIL or augment specific TIL functions to enhance tumor control.
    DOI:  https://doi.org/10.1101/2025.11.19.689204
  8. Cancer Immunol Res. 2025 Dec 05.
      Adoptive transfer of T lymphocytes specific for tumor-associated neoantigens can elicit immunity against solid tumors in patients. However, how these antigens impact T cell function, effector differentiation, and persistence remains unclear. We examined how an identical CD8+ T cell product was shaped by melanoma expressing either a low-avidity tumor-associated antigen or high-avidity neoantigen, and kinetically profiled T cell differentiation in these two contexts across host tissues. High-avidity neoantigen expression was sufficient to activate naïve CD8+ T cells - leading to robust tumor regression and long-term protective immunity upon tumor rechallenge. Mechanistically, transferred naïve CD8+ T cells reacting to high-avidity neoantigen exhibited enhanced cytokine production, heightened effector function, and sustained persistence compared to the low-avidity wild-type tumors. Antitumor activity to these high-avidity tumors was preserved even in the absence of functional host T and B lymphocytes, and early lymph node trafficking was found to be essential for ACT efficacy. Expanded effector or stem-memory T cells were compared to the naïve pmel-1 T cell product. Stem-memory but not effector-memory cells exhibited similar antitumor efficacy and lymph node trafficking patterns to the naïve cells in mice with high-avidity neoantigen tumors. These findings highlight how differential tumor antigens shape divergent cellular fate and uncover a critical role of T cell trafficking in lymph nodes in shaping high-avidity neoantigen-specific antitumor responses.
    DOI:  https://doi.org/10.1158/2326-6066.CIR-25-0514
  9. J Immunother Cancer. 2025 Dec 01. pii: e012800. [Epub ahead of print]13(12):
       BACKGROUND: Optimizing T cell activation strength is emerging as a critical factor in improving adoptive cellular therapy (ACT). We previously reported that neoantigen-specific T cell receptor (TCR) clonotypes from a patient with metastatic melanoma exhibited enhanced resilience to repeated stimulation when initially activated at moderate levels.
    METHODS: Building on these observations, we applied transient, low-dose MEK inhibition (MEKi) to fine-tune T cell signal strength during early activation. We evaluated this combinatorial strategy in vitro using co-cultures of CD8+ T cells engineered with patient-derived neoantigen-specific TCRs, alongside chimeric antigen receptor-T cells, bispecific T cell engagers, and non-engineered tumor-infiltrating lymphocytes (TILs). In vivo efficacy was evaluated in a xenograft model with intravenous TCR-T cell transfer and systemic low-dose MEKi.
    RESULTS: MEKi co-treatment induced a more tempered activation profile that enhanced T cell proliferation, fitness, and persistence under strong stimulation. These effects were consistent across various in vitro and in vivo models for engineered T cells as well as primary melanoma-derived TILs. MEKi dampened the pro-inflammatory T cell activation profile, most notably diminishing tumor necrosis factor (TNF) secretion, mechanistically driven by coordinated and selective disruption of the key transcriptional regulators nuclear factor kappa-light-chain-enhancer of activated B cells (NFκB) and nuclear factor of activated T cells (NFAT) while partly preserving activator protein 1 (AP-1) activity.
    CONCLUSION: These findings highlight moderate activation as a critical determinant of engineered T cell long-term performance. Low-dose MEKi offers a therapeutic tool for fine-tuning T cell activation and enhancing ACT efficacy.
    Keywords:  T cell receptor - TCR; adoptive cell therapy - ACT; combination therapy; immunotherapy
    DOI:  https://doi.org/10.1136/jitc-2025-012800
  10. Front Immunol. 2025 ;16 1684842
      The use of tumor-reactive T cells in targeted tumor elimination holds significant potential for cancer immunotherapy, such as Tumor-Infiltrating Lymphocyte (TIL) therapy and TCR-T adoptive immunotherapy. Critical aspects of the effective clinical application of these immunotherapies include the enrichment and selection of tumor antigens and their corresponding reactive T cells. However, current in vitro methods for expanding and screening tumor antigen-reactive T cells remain inefficient. One reason for this inefficiency is the dysfunctional state of tumor-reactive T cells, which limits their expansion and activation. To address this challenge, we developed an optimized dendritic cell-based culture system, in which dendritic cells simultaneously express interleukin-12 and granulocyte-macrophage colony-stimulating factor (12GM-DCs), to enhance the expansion of tumor-reactive T cells. We found that 12GM-DCs can enrich reactive T cells targeting various tumor antigens, including virus-associated tumor antigens, tumor-associated antigens, mutant tumor neoantigens, and patient-specific tumor neoantigens. Moreover, 12GM-DCs increased the proportion of antigen-specific T cells, enhanced the activation of those T cells, and promoted the maintenance of a memory phenotype. The cytotoxicity of these antigen-reactive T cells was increased after co-culture with 12GM-DCs, likely due to the increased secretion of interferon-γ and granzyme B. Importantly, these functions and phenotypic advantages of tumor antigen-reactive T cells derived from the 12GM-DC culture system could be effectively maintained and the antitumor activity was also enhanced in tumor-burden mice. Our 12GM-DC coculture system effectively enriches antigen-specific T cells and has the potential to advance the clinical application of cancer immunotherapy by targeting tumor antigens and their reactive T cells.
    Keywords:  DC; GM-CSF; IL-12; enrichment and selection; reactive T cells
    DOI:  https://doi.org/10.3389/fimmu.2025.1684842
  11. Clin Cancer Res. 2025 Dec 01.
       BACKGROUND: HER2DX is a validated genomic assay used to support treatment decisions in early-stage HER2-positive (HER2+) breast cancer. It provides three scores: relapse risk, likelihood of pathologic complete response (pCR), and ERBB2 mRNA expression. This study aimed to evaluate the association between HER2DX and histopathologic features and to assess its relationship with pCR after neoadjuvant therapy.
    METHODS: Patients with newly diagnosed stage I-III HER2+ breast cancer were analyzed based on available HER2DX results during routine care in Spain (January 2022-June 2025). Centralized HER2DX testing was performed on formalin-fixed, paraffin-embedded tumor samples. Histopathologic analysis included tumor grade, hormone receptor (HR) status, histological subtype, Ki67 index, HER2 immunohistochemistry (IHC) score, stromal tumor-infiltrating lymphocytes (TILs), tertiary lymphoid structures (TLS), and spatial immune distribution. Univariate and multivariable logistic regression analyses were conducted to identify factors associated with pCR after neoadjuvant trastuzumab-based therapy.
    RESULTS: A total of 410 HER2+ tumors were analyzed, and 250 patients received neoadjuvant trastuzumab-based therapy with available surgical outcomes (36.0% achieved a pCR). HER2DX pCR scores were significantly associated with all eight histopathologic features, whereas relapse risk and ERBB2 scores were associated with five and two, respectively. TILs correlated with the immune/immunoglobulin (IGG) signature (r=0.59), and Ki67 with the proliferation signature (r=0.50). The HER2DX pCR score remained the only independent predictor of pCR in multivariable analysis (odds ratio [OR]=1.77, 95% CI 1.08-2.97, p=0.030).
    CONCLUSIONS: HER2DX reflects key biological and pathological features of HER2+ breast cancer and independently predicts pCR, supporting its utility for individualized treatment decision-making.
    DOI:  https://doi.org/10.1158/1078-0432.CCR-25-3123
  12. Anticancer Res. 2025 Dec;45(12): 5567-5577
       BACKGROUND/AIM: The relationship between peripheral eosinophil levels and prognosis or the tumor microenvironment (TME) in patients undergoing esophagectomy for esophageal cancer (EC) remains unclear. This study aimed to investigate the prognostic significance of preoperative peripheral eosinophils and their association with tumor-infiltrating immune cells.
    PATIENTS AND METHODS: A total of 243 patients who underwent curative esophagectomy for EC were retrospectively analyzed. Patients were classified into two groups based on a preoperative peripheral eosinophil cut-off value of 1.6%, determined using Youden's index. Survival outcomes were compared between the groups, and prognostic factors were identified using Cox proportional hazards modeling. In a subset of 96 patients with available data, correlations between preoperative eosinophil levels and tumor-infiltrating CD8+ and CD163+ cells in the TME were evaluated.
    RESULTS: Overall survival (OS) and relapse-free survival (RFS) in the preoperative peripheral eosinophil <1.6% group were significantly worse than those in the preoperative peripheral eosinophil ≥1.6% group. Multivariate analysis revealed that peripheral eosinophil <1.6% was an adverse prognostic factor for OS [hazard ratio (HR)=1.65; 95% confidence interval (CI)=1.03-2.64] and RFS (HR=1.63; 95%CI=1.06-2.49). Additionally, preoperative peripheral eosinophil count positively correlated with the number of TI CD8+ cells (r=0.26), while peripheral eosinophils% and the number of TI CD163+ cells had no correlation (r=-0.03).
    CONCLUSION: Preoperative low peripheral eosinophil count may be a prognostic factor in esophagectomized patients for EC. Additionally, peripheral eosinophil rate and the number of TI CD8+ cells had positive correlation.
    Keywords:  Esophagectomy; esophageal cancer; peripheral eosinophils; tumor-infiltrating lymphocytes
    DOI:  https://doi.org/10.21873/anticanres.17891
  13. Front Oncol. 2025 ;15 1710544
       Introduction: Thymic epithelial tumors (TETs), encompassing thymomas and thymic carcinomas, are rare malignancies originating from thymic epithelial cells. This study aimed to characterize tumor-infiltrating immune cells (TIIC) within the tumor microenvironment (TME) and evaluate their prognostic significance in TETs.
    Methods: We retrospectively analyzed 125 patients with surgically resected TETs (2009-2021). Immunohistochemical staining of tumor specimens was performed to assess TIIC distribution, with significant associations between immune markers and survival outcomes evaluated using Cox regression.
    Results: Among the analyzed markers, CD20, CD204, CD206, and CD47 emerged as potential predictors for disease-free survival (DFS), while CD20 and CD204 showed prognostic relevance for overall survival (OS). Specifically, stromal CD20+ TIIC density was independently associated with prolonged DFS(HR=4.74, 95% CI(1.673-13.434), P=0.003) and OS (HR=5.086, 95% CI(1.391-18.594), P=0.014), whereas elevated CD204+ TIIC infiltration correlated with reduced DFS(HR=0.154, 95% CI(0.043-0.547), P=0.004) and OS(HR=0.169, 95% CI(0.056-0.607), P=0.002).
    Conclusion: These findings suggest that targeting M2 macrophage-driven immunosuppression may enhance therapeutic efficacy in TETs.
    Keywords:  CD20; CD204; thymic epithelial tumors; tumor microenvironment; tumor-associated macrophages
    DOI:  https://doi.org/10.3389/fonc.2025.1710544
  14. Anticancer Res. 2025 Dec;45(12): 5543-5555
       BACKGROUND/AIM: Tertiary lymphoid structures (TLS) have become the focus of antitumor immunity. However, the prognostic significance of TLS in epithelial ovarian cancer (EOC) treated with primary debulking surgery (PDS) or interval debulking surgery (IDS) remains unclear. Therefore, we aimed to examine TLS in tumor tissues collected during PDS and IDS for patients with EOC to evaluate its prognostic significance.
    PATIENTS AND METHODS: We examined TLS in EOC tumor tissues obtained during PDS or IDS from patients treated between 2017 and 2020 at the National Cancer Center Hospital East, Kashiwa, Japan. The association of tumor-infiltrating lymphocyte frequency, TLS presence, and programmed death-ligand 1 (PD-L1) expression with progression-free (PFS) and overall (OS) survival, and the association between TLS and PD-L1 expression were analyzed.
    RESULTS: Overall, 25 specimens (15 from PDS and 10 from IDS) were analyzed. The presence of TLS was associated with a significantly longer OS (median: 32.3 vs. 21.3 months, p=0.0455) in patients who underwent PDS but not in patients who underwent IDS (median: could not be calculated, p=0.9678). No association was identified between TLS and PFS in patients with PDS or with IDS (median: 31.1 vs. 17.3 months, p=0.3970; median: 28.7 vs. 16.3 months for median without TLS, p=0.1653). However, TLS was positively correlated with PD-L1 positivity (p=0.0094).
    CONCLUSION: The prognostic impact of TLS, specifically in pre-chemotherapy specimens, and a positive association between TLS and PD-L1 indicate the potential of TLS as a meaningful biomarker for understanding antitumor immunity and developing immunotherapy for EOC.
    Keywords:  Ovarian cancer; tertiary lymphoid structure; tumor microenvironment; tumor-infiltrating lymphocytes
    DOI:  https://doi.org/10.21873/anticanres.17889
  15. Clin Cancer Res. 2025 Dec 04.
       PURPOSE: Unsatisfactory outcomes in pancreatic ductal adenocarcinoma (PDAC) highlight the need to identify precision-based treatment modalities. We aimed to utilize patient-derived organoids (PDOs) to predict the most effective individual components of potential combination therapies.
    EXPERIMENTAL DESIGN: Autologous αβ and γδ-enriched tumor infiltrating lymphocyte (TIL) and PDO cultures were established from resected PDAC tissue. PDOs were characterized by immunostaining, targeted next-generation sequencing, and drug screening with standard-of-care multidrug chemotherapeutic regimens. Expanded TIL cultures were profiled through flow cytometry, sequencing, and potency against autologous PDOs.
    RESULTS: PDO cultures were established with an 80% success rate. In addition to faithfully recapitulating molecular and histological features of the parental tumor, PDOs were sufficiently expanded for pharmacotyping within a clinically relevant timeframe of 36 days. Notably, PDO chemotherapeutic sensitivity profiles correlated with patient serum CA 19-9 dynamics and recurrence free survival. Furthermore, expanded γδ-enriched TIL supported the activation of αβ TCR+ cells and demonstrated more potent functionality in response to autologous PDO targets. Importantly, infiltration of γδ T cells within pancreatic tumor tissue was associated with improved overall survival.
    CONCLUSIONS: We confirm the feasibility of generating PDOs within a clinically relevant timeframe and provide evidence of their utility for advancing therapeutic success in PDAC.
    DOI:  https://doi.org/10.1158/1078-0432.CCR-25-1110
  16. Front Oncol. 2025 ;15 1673810
       Background: The development of a robust and clinically applicable predictive model for pathological complete response (pCR) following neoadjuvant therapy (NAT) in human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC) is of critical importance.
    Methods: In this retrospective study, 393 female patients with stage II-III BC who received NAT followed by surgery between May 2021 and December 2023 were included. Clinicopathological data, apparent diffusion coefficient (ADC) values from breast MRI, and pathological remission after NAT were collected. The change rate of ADC values after two cycles of NAT (ΔADC0-2%) was calculated. The efficacy of NAT regimens containing trastuzumab plus pertuzumab (HP) and trastuzumab plus pyrotinib (HPy) was compared. A nomogram predicting pCR was constructed, and its performance was evaluated. The model was internally validated using the bootstrap resampling method.
    Results: The rate of total pathological complete response (tpCR) in the overall population was 68%. There was no statistically significant difference in tpCR between the HP and HPy groups (P > 0.05). Hormone receptor (HR) negativity, HER2 3+, high Ki-67 index, moderate-highly (M-H) infiltrated tumor-infiltrating lymphocytes (TILs), and ΔADC0-2% > 36.2% were independently associated with tpCR (P < 0.05). The nomogram integrating these variables exhibited good discrimination (AUC, 0.75) and calibration ability (P = 0.925), as well as valuable clinical applicability.
    Conclusion: Both HP and HPy combined with chemotherapy can be considered as optional NAT regimens for HER2-positive BC. The nomogram incorporating common clinical indicators provides a basis for clinicians to predict NAT efficacy at an earlier stage.
    Keywords:  HER2-positive breast cancer; different anti-HER2 targeted therapies; neoadjuvant therapy; nomogram; pathological complete response; real world
    DOI:  https://doi.org/10.3389/fonc.2025.1673810
  17. J Nanobiotechnology. 2025 Dec 01.
       BACKGROUND: Concurrent chemoradiotherapy (CRT) combined with PD-1/PD-L1 targeting immunotherapy (IM) has emerged as a promising treatment for locally advanced esophageal squamous cell carcinoma (ESCC). However, individual responses to this treatment vary, highlighting the need for predictive biomarkers to improve therapeutic efficacy. Interleukin-15 (IL-15) has shown potential in enhancing anti-tumor immunity, but its role in ESCC remains poorly defined.
    METHODS: We analyzed clinical cohorts of ESCC patients who underwent radiotherapy (RT) and IM, utilizing blood and tissue samples collected pre- and during treatment. A multi-omics approach combining ELISA, flow cytometry, single-cell RNA sequencing, and spatial analysis was employed to investigate the role of IL-15 within the tumor microenvironment (TME).
    RESULTS: Elevated IL-15 levels during RT combined with IM correlated with improved patient prognosis. IL-15 was predominantly expressed by macrophages, endothelial cells, dendritic cells, and CD4+ T cells. It enhanced the activation and maintenance of stemness in progenitor-exhausted CD8+ T (Tpex) cells via trans- or cis-presentation. The spatial proximity between presenting cells and Tpex cells was crucial for activating the IL-15 pathway and promoting immune responses within the TME. Additionally, preclinical mouse models demonstrated that combining RT, anti-PD-1, and IL-15/IL-15 receptor alpha treatment resulted in significant anti-tumor effects.
    CONCLUSIONS: Our findings suggest that IL-15 levels could serve as a biomarker for identifying ESCC patients who are likely to benefit from RT and IM. These results also provide a rationale for targeting IL-15 as a novel therapeutic strategy to enhance treatment outcomes for ESCC patients.
    Keywords:  CD8+ T cell; Esophageal squamous cell carcinoma; IL-15; Immunotherapy; Radiotherapy
    DOI:  https://doi.org/10.1186/s12951-025-03881-2
  18. bioRxiv. 2025 Nov 20. pii: 2024.09.26.615179. [Epub ahead of print]
      T cells are central to immune defense, yet existing molecular and phenotypic assays do not fully capture a cell's intrinsic immune potential. Here we show that a single physical property, buoyant mass, reveals hidden heterogeneity within phenotypically similar, resting CD8 + T cells. Using suspended microchannel resonator measurements, we identify two distinct populations: "light" cells, enriched for mitochondrial content but prone to delayed activation and exhaustion, and "heavy" cells, biosynthetically poised for proliferation and memory formation. In patients with melanoma receiving immune checkpoint blockade, pre-treatment buoyant mass profiling of circulating T cells predicted therapeutic response with an accuracy comparable with standard tumor-derived biomarkers. Our findings establish buoyant mass as a label-free, stimulation-independent measure of systemic T cell fitness, providing a rapid and broadly applicable framework for immune profiling and response prediction in cancer and beyond.
    DOI:  https://doi.org/10.1101/2024.09.26.615179
  19. J Cancer. 2025 ;16(15): 4390-4399
      Background: Gastric cancer remains one of the most common causes of cancer death, with a notably high incidence in East Asian countries. Regulatory T cells (Tregs) suppress antitumor immunity in the tumor microenvironment, and recent studies have identified C-C motif chemokine receptor 8 (CCR8) as a selective marker for tumor-infiltrating activated Tregs. However, the role of CCR8⁺ Tregs in gastric cancer remains unclear. Methods: This study retrospectively analyzed 80 gastric cancer patients who underwent curative resection. Immunohistochemistry dual staining for CCR8/Foxp3 and granzyme B/CD8 was performed, followed by automated image analysis and spatial profiling. The correlation between CCR8⁺ Tregs and CD8⁺ T cells, as well as their prognostic significance, was evaluated. Results: CCR8⁺ Treg density positively correlated with CD8⁺ T cell infiltration. However, a low CD8⁺ T cell/CCR8⁺ Treg ratio was significantly associated with worse recurrence-free survival (P = 0.023). Reduced granzyme B expression was observed in CCR8⁺ Treg-dense hotspots, suggesting the presence of a localized immunosuppressive environment. Spatial analysis revealed that CCR8⁺ Tregs were preferentially localized at the tumor invasion front. Furthermore, distance analysis showed that fewer CD8⁺ T cells were present around CCR8⁺ Tregs than around CCR8⁻ Tregs, suggesting a localized immunosuppressive effect that may restrict CD8⁺ T cell proliferation. Conclusions: Our findings suggest that CCR8⁺ Tregs suppress antitumor immunity in gastric cancer by affecting surrounding CD8⁺ T cells through spatial segregation. Targeting CCR8⁺ Tregs may offer a promising strategy to improve the efficacy of immunotherapy in gastric cancer.
    Keywords:  CCR8⁺ regulatory T cells; anti-CCR8 therapy; gastric cancer; spatial analysis; tumor microenvironment
    DOI:  https://doi.org/10.7150/jca.121363
  20. Breast Cancer Res. 2025 Dec 05. 27(1): 209
       PURPOSE: We hypothesize that SFRP2 is a promising target for Triple Negative Breast Cancer (TNBC).
    EXPERIMENTAL DESIGN: 1. Multiplex immunohistochemistry (IHC) was performed on human TNBC to identify SFRP2 localization in the tumor microenvironment. 2. Tumor associated macrophages (TAMs) were isolated from E0771.LMB breast tumors. TAMs were treated with hSFRP2 mAb (10 µM) or control (10 µM) for 1 h and analyzed by western blot and qRT-PCR for IFN-ϒ. 3 SFRP2 and IFN-ϒ mRNA expression levels were analyzed from the Cancer Genome Atlas (tCGA) for breast cancer patients using least squares-linear regression analysis. 4. PY8119 or E0771.LMB TNBC cells were injected i.v. into mice, and mice were treated with either IgG1 or hSFRP2 mAb every 3 days. Lung metastases were counted after 4 weeks and analyzed by IHC for M1/M2 ratio. 5. MDA-MB-231 TNBC cells were injected into the mammary fat pad, and when tumors were established, mice were treated with IGg1 or hSFRP2 mAb every 3 days i.v. for 79 days and tumor volumes were compared. 6. Wild-type (WT) MDA-MB-231 and doxorubicin-resistant MDA-MB-231 cells were treated with hSFRP2 mAb and apoptosis was compared.
    RESULTS: 1) Multiplex IHC on human breast tumors showed that SFRP2 localized to tumor cells (87%), TAMs (90%), and tumor-infiltrating lymphocytes (TILs) (96%) in the microenvironment. 2) TAMs treated with hSFRP2 mAb had an increase in IFN-ϒ mRNA by 2.35 ± 0.08-fold (n = 3, p = 0.02) and protein levels by1.9-fold compared to control. 3). Analysis of 1075 breast cancer patients from TCGA database revealed a significant negative association between SFRP2 mRNA and IFN-ϒ expression (p < 0.0001). 4) hSFRP2 mAb reduced lung metastases in EO771.LMB (n = 15, p < 0.05) and PY8119 (n = 11, p < 0.05) mice with an increase the M1/M2 ratio in lungs (n = 3, p = 0.02). 5) hSFRP2 mAb inhibited MDA-MB-231 growth in vivo by 61% percent (n = 9, p < 0.001). 6) hSFRP2 mAb promoted apoptosis in doxorubicin-resistant cells (n = 6, p < 0.0001).
    CONCLUSIONS: SFRP2 localizes to tumor, TAMs and TILs in the tumor microenvironment and is negatively associated INF-ƴ in human tumors. hSFRP2 mAb reduces primary and metastatic TNBC growth, increases INF-ƴ from TAMS, boosts the M1/M2 ratio in lung metastases, and induces apoptosis in doxorubicin-resistant cells.
    Keywords:  Apoptosis; Biodistribution; CD38; Chemotherapy resistance; Immunotherapy; M1; M2; T-cells; Tumor microenvironment; WNT
    DOI:  https://doi.org/10.1186/s13058-025-02176-6
  21. Br J Cancer. 2025 Dec 01.
       INTRODUCTION: Tumour antigen-specific CD8+CD39+ T cells (TSTs) are crucial components of anti-tumour adaptive immunity, which in tumour microenvironment (TME) may be found at various differentiation stages, from early stem-like states to terminal stages of exhaustion. Our aim was the evaluation of TSTs quantitative and qualitative characteristics in hepatocellular carcinoma (HCC) TME, depending on whether they exhibit stem-like or exhaustion features.
    METHODS: We analyzed 100 HCC patients undergoing curative hepatectomy. Multiplex immunohistochemistry (CD8/CD39/TCF1, CD8/CD39/TOX) was applied on tissue microarray sections with digital imaging used to evaluate T cell infiltration in tumour center, periphery and adjacent non-neoplastic liver. Tertiary lymphoid structures (TLS) were assessed on H&E-stained slides.
    RESULTS: In HCC TME, 72% of CD8+ T cells co-express CD39, while 44% of CD8+CD39+ TSTs co-express TCF1 (stem-like) and over 50% co-express TOX (exhausted). High CD8+CD39+ T cell density in tumour periphery was linked to longer overall survival (p = 0.016). Increased CD8+CD39-TCF1+ T cell infiltration in tumour center and periphery correlated with worse prognosis (p = 0.009). TLS presence was associated with high TST density (p < 0.001).
    CONCLUSIONS: Patients with HCC and high CD8+CD39+ TSTs density exhibiting a tumour-reactive phenotype have improved survival, suggesting the potential role of CD8/CD39 immunohistochemistry as a prognostic tool for personalised therapeutic strategies.
    DOI:  https://doi.org/10.1038/s41416-025-03226-8
  22. Front Immunol. 2025 ;16 1704404
      Natural killer (NK) cells have been engineered to express chimeric antigen receptors (CARs) to enhance their cytotoxic capabilities through CAR-mediated activation, a strategy that has yielded promising advancements in cancer treatment in recent pre-clinical and clinical trials. However, the use of CAR-NK cells for the treatment of solid tumors has presented challenges due to limited in vivo CAR-NK efficacy, expansion, persistence, and the suppressive tumor microenvironment. Many groups have developed IL-15 cytokine-armored CAR-NK therapeutics targeting various cancers to overcome these challenges. However, preclinical in vivo studies using immunodeficient mice have encountered instances of significant toxicity without evidence of cytokine release syndrome. The lack of an intact immune system likely allows for unchecked in vivo expansion of cytokine armored CAR-NK cells, leading to early mortality in immunodeficient mice following treatment with these cells. We speculate that the use of humanized mice will allow for engraftment of tumor and alleviate cytokine armored CAR-NK toxicity, thereby allowing for effective assessment of CAR-NK efficacy in the absence of toxicity.
    Keywords:  CAR-NK cells; CAR-T cell therapy; IL-15 cytokine-armored CAR-NK; chimeric antigen receptors (CARs); cytokine release syndrome; cytokine release syndrome (CRS); natural killer (NK) cells
    DOI:  https://doi.org/10.3389/fimmu.2025.1704404
  23. Cell Death Discov. 2025 Dec 02.
      Hepatocellular carcinoma (HCC) is an aggressive liver cancer with high recurrence and poor prognosis. This study aims to explore USP13's role in HCC progression and assess its potential as a therapeutic target to induce ferroptosis and enhance immune response. HCC patient-derived organoids (PDOs), HCC cell lines and animal models were utilized to evaluate the anti-cancer responses of USP13 inhibition. We analyzed the correlation of USP13 expression and immune cell infiltration using single-cell RNA sequencing, flow cytometry analysis. A USP13 inhibitor, 2-Methoxyestradiol (2-Met), was used to evaluate its therapeutic efficacy. USP13 was found to be highly expressed in HCC tissues and was correlated with poor prognosis. Single-cell RNA sequencing analysis indicated that high expression of USP13 in HCC cells was associated with decreased enrichment of CD8 + T cells in the tumor microenvironment (TME). Targeting USP13 reduced HCC cell proliferation, stemness, and cholesterol metabolism while promoting ferroptosis and enhancing T cell-mediated cytotoxicity. Mechanistically, USP13 stabilized ACLY via inhibiting the K48-specific poly-ubiquitination process on ACLY protein at the K726 site. Under hypoxia condition, HIF-1α upregulates the transcription of USP13 by binding to its promoter region, which stabilizes ACLY protein. Overall, this research reveals that hypoxia-induced USP13 expression drives ferroptosis resistance and tumor immune evasion in hepatocellular carcinoma through the stabilization of ACLY. Pharmacological inhibition or knockdown of USP13 impedes HCC progression, induces ferroptosis, and enhances T cell-mediated cytotoxic effects. These results highlight that USP13 could be a promising therapeutic target for HCC.
    DOI:  https://doi.org/10.1038/s41420-025-02869-z
  24. Front Immunol. 2025 ;16 1676581
      The tumor immune microenvironment plays a critical role in tumor progression and responses to immunotherapy. Nevertheless, its cellular complexity and heterogeneity remain incompletely understood. In this study, we employed high-resolution single-cell RNA sequencing on CD45+ immune cells isolated from ten syngeneic murine tumor models, representing seven distinct cancer types under treatment-naïve conditions, thereby enabling a comprehensive profiling of tumor-infiltrating immune cells. We identified seven principal immune cell populations and provided an in-depth characterization of T cells, NK/innate lymphoid cells, dendritic cells, monocytes/macrophages, and neutrophils. Cross-species analyses further delineated conserved immune cell states and transcriptomic features within the T cell and monocyte/macrophage compartments that are shared across syngeneic models and human tumors. To investigate the functional relevance of the predominant monocyte/macrophage compartment and the notable presence of neutrophils in syngeneic tumors, we evaluated responses to anti-PD-1 therapy across various models and analyzed the enrichment of monocyte/macrophage subsets in tumors that responded to treatment. Furthermore, we conducted neutrophil depletion experiments using anti-Ly6G antibodies, administered both as monotherapy and in combination with PD-1 blockade. Remarkably, an interferon-stimulated gene-high (ISGhigh) monocyte subset was significantly enriched in models responsive to anti-PD-1 therapy. Neutrophil depletion resulted in variable antitumor effects across models but failed to enhance the efficacy of PD-1 blockade. In summary, our single-cell profiling offered a detailed atlas of the immune microenvironment across multiple syngeneic mouse tumor models, thereby enabling rational model selection for immuno-oncology studies. We uncovered an ISGhigh monocyte subset enriched in anti-PD-1 responsive models, and showed the context-dependent effects of neutrophil depletion on tumor immunity and immunotherapy, underscoring the heterogeneity and functional divergence of immune cell sublineages.
    Keywords:  anti-PD-1therapy; interferon-stimulated gene-high (ISGhigh) monocyte subset; neutrophil depletion; single-cell atlas; syngeneic murine models; tumor immune microenvironment
    DOI:  https://doi.org/10.3389/fimmu.2025.1676581
  25. J Transl Med. 2025 Nov 29.
       BACKGROUND: Inflammatory bowel disease (IBD) exhibits heterogeneous mucosal inflammation and variable responses to biologics therapy. This study aimed to identify the immune cell subsets and molecular programs driving disease pathogenesis and to develop predictive biomarkers for therapeutic outcomes.
    METHODS: We integrated single-cell RNA sequencing, bulk transcriptomic deconvolution, GWAS-based Mendelian randomization, and gut microbiome profiling across multiple IBD cohorts. Immune-microbial interactions were systematically characterized and linked with clinical phenotypes and treatment response. Immunohistochemistry was performed on colonic tissues from 12 IBD patients and 10 healthy controls to validate CCL5 and CD8 + T cell expression. Flow cytometric analysis of peripheral blood samples from 7 IBD patients and 12 healthy individuals was conducted to assess circulating CCL5 + CD8 + T cell proportions.
    RESULTS: CCL5 + effector CD8 + T cells emerged as key mediators of colonic inflammation, displaying high IFN-γ/TNF activity and RUNX3/NF-κB-coordinated transcriptional programs. Immunohistochemical validation demonstrated profoundly elevated CCL5 expression (median 4.170% vs. 0.3450%, P < 0.0001) and CD8 + T cell infiltration (median 2.025% vs. 0.2150%, P < 0.0001) in IBD colonic tissues. Peripheral blood showed modest trends toward increased CCL5 + CD8 + T cells, though far less pronounced than tissue changes. Tissue-resident effector CD8 + T cell abundance correlated with disease severity and infliximab resistance. Six causally associated genes (DMAJCI, RMF167, SPRY1, ZFP96, FKBP11, SELPLG) formed a predictive signature for diagnosis and treatment response. Microbiome analyses revealed disrupted networks and immune-microbiome coupling.
    CONCLUSION: CCL5 + CD8 + T cells are profoundly enriched in IBD colonic tissues and drive mucosal inflammation through pro-inflammatory pathways. A six-gene model, particularly involving FKBP11, demonstrated potential for disease stratification and infliximab response prediction. These findings highlight immune and microbial features of IBD that merit further functional and clinical validation.
    Keywords:  Biomarkers; Effector CD8+ t cells; Gut microbiome; Inflammation; Inflammatory bowel disease; Mendelian randomization; Single cell RNA sequencing
    DOI:  https://doi.org/10.1186/s12967-025-07509-9
  26. Front Immunol. 2025 ;16 1684655
       Background: In the last decade, chimeric antigen receptor (CAR)-modified T cells have revolutionized the treatment of hematologic malignancies. However, antitumor responses in solid tumors remain poor, and the difficulty in finding truly tumor-specific target antigens leads to a high risk of on-target/off-tumor toxicity. Transient modification with mRNA is gaining momentum as an alternative approach to viral transduction in order to achieve a better safety profile. On the other hand, generation of T cells secreting bispecific T cell engagers (TCEs) has been reported to outperform the antitumor efficacy of T lymphocytes expressing membrane-anchored CARs, due to the ability of the soluble TCEs to recruit unmodified bystander T cells.
    Methods: We have electroporated human primary T cells with in vitro transcribed mRNA encoding an anti-EGFR x anti-CD3 bispecific T cell engager. Such mRNA-modified T cells (STAREGFR-T cells) have been analyzed for anti-EGFR bispecific TCE secretion and for their ability to drive anti-tumor responses against EGFR-expressing cells, both in vitro and in vivo.
    Results: STAREGFR-T cells transiently secrete bispecific TCEs capable of redirecting T lymphocytes to exert tumor cell-specific killing in in vitro assays. Moreover, STAREGFR-T cells efficiently control tumor growth in in vivo xenograft models of solid malignancy.
    Conclusions: Our results strongly support mRNA-engineered TCE-secreting T cells as a promising therapeutic strategy for solid tumors.
    Keywords:  CAR-T cell; STAR-T cell; STAb-T cell; T cell engager (TCE); mRNA; solid tumors
    DOI:  https://doi.org/10.3389/fimmu.2025.1684655
  27. J Immunother Cancer. 2025 Nov 29. pii: e011959. [Epub ahead of print]13(11):
       BACKGROUND: Immune checkpoint blockade (ICB) therapy, while transformative in cancer treatment, is frequently complicated by immune-related colitis (irColitis), driven by poorly understood mechanisms.
    METHODS: An integrated analysis of single-cell RNA sequencing (scRNA-seq), T cell receptor (TCR) sequencing, and spatial transcriptomics was conducted to identify immune cell populations and associated signaling pathways driving irColitis. In vivo murine models of irColitis, along with flow cytometry and qPCR, were used to further validate these findings. To assess the functional roles of specific signaling pathways and cell types in driving irColitis, in vivo blockade of IL-23 and CXCL9/10 signaling was performed using neutralizing antibodies, and intestinal macrophages were depleted using clodronate liposomes. Additionally, the potential impact of these immune cells and signaling pathways on ICB therapy was evaluated through the integration of scRNA-seq and TCR sequencing with qPCR and flow cytometry.
    RESULTS: A pathogenic IFNG+IL17+CD4+ T cell subset with dual Th1/Th17 features, high clonal expansion, and differentiation trajectories from tissue-resident memory T cells (TRM) was identified in human irColitis lesions and murine models. IL-23 blockade reduced the frequency of IFNG+IL17+CD4+ T cells and mitigated colitis severity. Mechanistically, IL-23 promoted the expansion and survival of pathogenic Th17 (pTh17) precursors, while CXCL9/10-CXCR3 signaling facilitated their differentiation into IFN-γ-secreting effector cells. Intestinal macrophages were identified as major producers of IL-23, CXCL9, and CXCL10. Macrophage depletion markedly alleviated colitis and reduced pathogenic T cells. Crucially, IFNG+IL17+CD4+ T cells showed no association with antitumor immunity in colorectal cancer immunotherapy responders, suggesting their targeting would not affect ICB efficacy.
    CONCLUSIONS: IFNG+IL17+CD4+ T cells and CXCL9/10-producing macrophages are key mediators of irColitis. Targeting IL-23 signaling and intestinal macrophages represents a promising strategy to alleviate gut immunopathology without compromising the efficacy of ICB therapy.
    Keywords:  Colitis; Immune Checkpoint Inhibitor; Immune related adverse event - irAE; Macrophage; T cell
    DOI:  https://doi.org/10.1136/jitc-2025-011959