More than 180 companies are now developing over 200 chimeric antigen receptor T-cell (CAR-T) therapies, reflecting a period of rapid growth in cell therapy research. According to DelveInsight, both established pharmaceutical firms and newer biotech companies are expanding the scope of CAR-T, moving beyond cancer to include autoimmune diseases.
As of September 15, 2026, scientific literature documents 197 registered clinical trials of CAR-T therapies for autoimmune diseases, highlighting the technology's expansion beyond oncology.
CAR-T therapy modifies a patient’s own T cells to recognize and attack cancer cells. While this approach has changed treatment for some blood cancers, it still faces challenges: tumors can evade detection, resistance can develop, and results in solid tumors have been limited. Safety is also a concern, with risks such as cytokine release syndrome, neurotoxicity, and long-term immune suppression.
To address these issues, newer CAR-T designs are moving past the original models. Innovations include targeting multiple antigens, using switchable activation systems, improving co-stimulatory domains, and applying gene-editing techniques. Some companies are working on off-the-shelf allogeneic products, like Fate Therapeutics’ FT819 and Allogene Therapeutics’ ALLO-501A, which could make manufacturing more consistent and expand access for patients.
A 2026 review in Frontiers in Immunology emphasizes that most autoimmune CAR-T studies focus on CD19 targeting, with a major research trend being the shift from oncology to immunological indications. This aligns with the current expansion of company pipelines into autoimmune diseases.
The CAR-T pipeline is no longer limited to cancer. Descartes-08 from Cartesian Therapeutics is in Phase III trials for generalized myasthenia gravis, aiming to stop autoantibody production by targeting long-lived plasma cells. Bristol-Myers Squibb’s Zola-cel and Cabaletta Bio’s CABA-201 are in late-stage trials for systemic scleroderma and idiopathic inflammatory myopathy, focusing on B cell-driven autoimmune diseases.
CRISPR Therapeutics’ CTX112 uses CRISPR/Cas9 gene editing to improve cell persistence and lower the risk of graft-versus-host disease in B-cell cancers. CARSGEN Therapeutics’ CT1190B and Autolus Therapeutics’ AUTO-8 are advancing in relapsed or refractory lymphoma and multiple myeloma. Each therapy is defined by its target antigen, co-stimulatory domains, and manufacturing method, with some now in Phase III development.
DelveInsight’s report breaks down the pipeline by product type, clinical stage, administration route, and molecule type, and also tracks collaborations, licensing, and funding that shape the competitive field.
Since the first FDA approval of a CAR-T therapy in 2017, the field has grown quickly. Blood cancers remain the main focus, but trials are now exploring CAR-T in solid tumors, central nervous system cancers, liver and lung cancers, and a growing list of autoimmune diseases. The range of approaches—from autologous to allogeneic, single to dual targeting—shows a sector working to improve both effectiveness and safety.
With so many candidates in development, both the clinical and commercial stakes are high. The next generation of CAR-T therapies will depend on delivering lasting responses, manageable safety, and scalable production. The companies leading these efforts are shaping the future of precision cell therapy, and the results of ongoing trials will show which strategies can expand CAR-T’s impact beyond blood cancers.
