Expanding Access to CAR T-Cell Therapy Through Early Referral and Broader Eligibility

A panel of experts determined that early referral for chimeric antigen receptor (CAR) T-cell therapy, ideally at relapse and before the next treatment line, can expand access and improve outcomes, as multidisciplinary collaboration makes this option feasible for most patients despite comorbidities, according to an article published in Transplantation and Cellular Therapy.

“Despite the proven efficacy and safety profile of CAR T-cell therapies, timely identification and referral of eligible patients remains a significant challenge, especially in community oncology settings,” explained Mazyar Shadman, Fred Hutchinson Cancer Center, University of Washington in Seattle, Washington, and coauthors.

In a consensus report from 10 specialists in oncology, hematology, cardiology, and infectious diseases, experts agree that early referral and flexible eligibility criteria may be key to improving patient access to CAR T-cell therapy. Their guidance emphasizes 3 priorities: appropriate patient selection, timely referral, and coordinated posttreatment monitoring. These recommendations expand access and optimize outcomes for patients with relapsed or refractory (R/R) blood cancers.

The panel urged physicians to move away from applying autologous stem cell transplant (ASCT) criteria when evaluating candidates for CAR T-cell therapy. Unlike ASCT, CAR T-cell eligibility is broader: advanced age, marginal performance status, or lack of chemotherapy response should not automatically exclude patients. Instead, comorbidities such as cardiovascular, pulmonary, renal, or hepatic impairment can often be managed collaboratively with specialists. Patients with controlled infections, including HIV, hepatitis B, or hepatitis C, can also be considered. Even those with autoimmune disease, obesity, prior solid organ transplant, or secondary central nervous system (CNS) involvement may safely receive CAR T-cell therapy under expert guidance.

Age alone is a poor predictor of treatment success. Studies show that patients ≥80 years achieve efficacy and safety outcomes comparable to younger adults, though hospital stays may be longer. Likewise, poor performance status, cognitive decline, or psychiatric disorders should not preclude referral when multidisciplinary support is available. Social and caregiver support remain essential, particularly during the 2-week postinfusion monitoring period.

Timing remains critical. Experts recommend referring patients immediately upon disease relapse or refractoriness, ideally before starting the next line of therapy. Early referral allows time for cell collection, manufacturing, insurance approval, and logistical planning. Telehealth consultations can help expedite this process, especially for patients far from treatment centers.

Posttreatment, most adverse events such as cytokine release syndrome and neurotoxicity occur within the first two weeks. Reflecting this, the US Food and Drug Administration (FDA) recently reduced monitoring proximity requirements from four to two weeks and shortened driving restrictions from eight to 2 weeks. Longer-term follow-up should focus on infection prevention, vaccination, and vigilance for secondary malignancies, which may appear months after infusion.

“Timely referral should be made by the patient’s primary oncologist to specialists as soon as the disease is deemed relapsed or refractory and before a subsequent line of therapy is started to allow better care access and to improve treatment outcomes,” concluded the study authors.

Reference

Shadman M, Ahmed S, Byrne MT, et al. Who is eligible for CAR T-cell therapy? Expert perspectives on overcoming referral barriers. Transplant Cell Ther. Published online October 23, 2025. doi:10.1016/j.jtct.2025.10.025