Transplant Cell Ther. 2025 Oct 23. pii: S2666-6367(25)01528-3. [Epub ahead of print]
BACKGROUND: CD19-directed chimeric antigen receptor (CAR) T-cell therapies, including lisocabtagene maraleucel, axicabtagene ciloleucel, and tisagenlecleucel, have revolutionized the treatment landscape for patients with hematologic malignancies. However, identification and referral of patients who could benefit from treatment remains a significant challenge.
OBJECTIVE: To report expert recommendations for CAR T-cell therapy referral.
METHODS: Recommendations were gathered from 10 experts in oncology, hematology, cardiology, and infectious disease from a roundtable meeting and/or subsequent reviews from November 13, 2024, to June 9, 2025.
RESULTS: The authors considered the following potential factors: age, performance status, disease status, cardiovascular function, pulmonary function, renal function, hepatic function, infections, and psychological health. Based on existing evidence, the authors agreed that none of the factors discussed should preclude patients from receiving referrals/further evaluation for CAR T-cell therapy, particularly with current advances in supportive care and integration of services from other specialties. Timely referral should be made by the patient's primary oncologist to specialists as early as the disease is deemed relapsed or refractory, and preferably before the subsequent line of therapy is started to allow better access to care and to improve treatment outcomes. Before CAR T-cell therapy, holding therapy (before leukapheresis) and/or bridging therapy (after leukapheresis) may be given to patients with high-volume disease, in consultation with CAR T-cell therapy specialists. Based on the safety profile of CAR T-cell therapies, experts recommended flexible monitoring and transfer of care back to primary/community oncology physicians, starting from 2 weeks after infusion to improve access to this potentially curative therapy. Adaptations to clinical practice based on the most recent regulations, policy requirements, and institutional guidelines should be made as needed.
CONCLUSIONS: In summary, a panel of 10 experts provided recommendations for timely patient referral for CAR T-cell therapy upon occurrence of relapsed or refractory disease and before initiation of subsequent line of therapy to improve care access and treatment outcomes. Experts noted that with close collaboration between CAR T-cell therapy specialists and other medical disciplines, CAR T-cell therapy remains a feasible option for most patients despite their comorbidities.
Keywords: Axicabtagene ciloleucel; Brexucabtagene autoleucel; Cellular therapy; Chimeric antigen receptor T-cell therapy; Expert perspectives; Lisocabtagene maraleucel; Lymphoma; Patient identification; Patient selection; Referral; Tisagenlecleucel