Autologous CAR-T cell immunotherapy for autoimmune diseases: a systematic review

Autologous CAR-T cell immunotherapy has emerged as a promising treatment for autoimmune disease, achieving high remission rates with manageable side effects. However, concerns remain regarding long-term safety, durability, and manufacturing scalability. Aim(s)/objectives: this systematic review assesses the therapeutic potential of autologous CAR-T cells. The feasibility of autologous CAR-T manufacturing and future directions will also be discussed. Methods: 27 studies (2019–2025) from 3 databases were reviewed to assess the clinical efficacy and safety of autologous CAR-T cells in autoimmune disease. Of 131 patients treated, 58% achieved complete remission, while an additional 35.8% demonstrated clinically significant improvement. Mild cytokine release syndrome (grades 1–2) was reported in 51.9% and 4.6% experienced immune effector cell-associated neurotoxicity syndrome. Other side effects, often linked to lymphodepleting chemotherapy, were manageable. Limitations of the review include a small sample size, a non-randomized design, and a short follow-up. Conclusions: CAR-T immunotherapy achieves effective remission of several autoimmune disorders with manageable toxicity. Larger, longer-term controlled trials are needed to confirm these findings and the durability of response. Emerging innovations like self-regulating CAR-T cells and manufacturing developments such as T-Charge™ and in vivo manufacturing may improve efficiency and scalability for widespread clinical use.