Advancing access to CAR T-cell therapy: insights and real-world experience from a community oncology practice.

Introduction: Chimeric antigen receptor (CAR) T-cell therapy has transformed the treatment of hematologic malignancies, offering durable remissions for patients with otherwise refractory disease. However, access to these therapies remains limited and primarily restricted to academic medical centers, contributing to significant geographic and demographic disparities in care delivery. Methods: We conducted a retrospective review of a community practice-based outpatient CAR T-cell therapy program, independent of academic or hospital affiliation, treating patients with relapsed hematologic malignancies. The implementation process, completed over six months, followed a structured series of steps to ensure safe and effective outpatient administration. Results: Between April 19, 2022, and December 18, 2024, 41 adult patients received outpatient CAR T-cell therapy. Products administered included liso-cel (n=19), ide-cel (n=12), axi-cel (n=8), and brex-cel (n=2). CRS occurred in 68% of patients, and ICANS in 22%. Hospital admission was required for 49% of patients, with 15% needing ICU care. Clinical remission rates at day 100 and 1 year were consistent with published data for each product. Patients receiving 4-1BB co-stimulatory domain CAR T-cells were observed to have numerically lower hospitalization rates (32%) compared to those receiving CD28-based products (100%). No unexpected safety concerns were observed under home-based monitoring. Conclusion: This analysis demonstrates that outpatient CAR T-cell therapy can be safely delivered in a community oncology practice setting, offering a viable solution to expand access and reduce geographic barriers. Despite clinical success, payer reluctance remains a significant barrier, highlighting the urgent need for policy reform to enable community-based delivery of advanced therapies.