Current landscape of academic and point of care CAR-T cell therapy in low-middle income countries

Chimeric antigen receptor T-cell (CAR-T) therapy has emerged as a transformative treatment for patients with relapsed or refractory hematologic malignancies, offering new possibilities beyond conventional transplantation. Since their approval in high-income countries, CAR-T products have demonstrated remarkable efficacy; however, their implementation in low- and middle-income countries (LMICs) remains limited due insufficient infrastructure, complex regulatory requirements and high costs. In some countries, like Mexico, these barriers are particularly pronounced, with limited access to clinical-grade vectors, early phase clinical research programs, and lack of government and private sector infrastructure and funding opportunities. Facing these challenges, there is a substantial patient population with B-cell acute lymphoblastic leukemia, multiple myeloma, or diffuse large B-cell lymphoma, who could benefit from CAR-T therapy. Advances in point-of-care manufacturing within academic settings –particularly the use of closed, semi-automated systems– have demonstrated feasibility in LMICs, by reducing costs and simplifying procedures, while maintaining product quality. These approaches may provide a viable alternative to commercial products, with the potential to lower the economic burden and increase accessibility. Regulatory innovation with the establishment of expert multidisciplinary oversight committees, will also be critical to ensure safe implementation. Ultimately, CAR-T therapy in LMICs is both a scientific and public health opportunity, and its integration into healthcare systems will depend on collaborative strategies that address financial, logistical, and policy barriers. By highlighting our experience, this review underscores the importance of developing locally adapted solutions to expand access to advanced cellular therapies in resource-constrained settings.