CAR-T for autoimmune disease

• ClinicalTrials.gov lists 336 ¹ interventional studies of CAR-T, CAR-NK or T-cell-engager therapies in autoimmune disease, excluding studies that also list a cancer. 279 ² of them are active, and only 8 ³ are registered as Phase 3.
• 300 ⁴ of these studies started between January 2023 and September 2026: 185 ⁵ with a site in China and 67 ⁶ with a site in the United States.
• Starts rose from 6 ⁷ in 2022 to 91 ⁸ in 2024 and 112 ⁹ in 2025.
• CD19-directed therapies appear in 195 ¹⁰ of the new studies, and lupus is the leading disease with 147 ¹¹.

The first reports of drug-free remission in lupus after CD19 CAR-T were published by Erlangen investigators in 2021 (NEJM) and 2022 (Nature Medicine). Registered trials followed a year or two later: 7 ¹² started in 2021, 17 ¹³ in 2023, then 91 ⁸ in 2024 and 112 ⁹ in 2025.

China accounts for most of the wave. Studies with a China site rose from 9 ¹⁴ in 2023 to 76 ¹⁵ in 2025, while studies with a US site went from 5 ¹⁶ to 21 ¹⁷. Many Chinese studies are run by hospitals, including Zhejiang University, Tongji Medical College and the Institute of Hematology in Tianjin, often with local CAR-T companies. That lets them treat patients quickly under investigator-initiated rules.

CD19 is the default target, named in 195 ¹⁰ studies started since 2023. BCMA-directed therapies, which also reach long-lived plasma cells, appear in 96 ²⁷, often as CD19 x BCMA dual-target products.

The more important shift is in format. Allogeneic or universal products appear in 72 ²⁸ new studies, and CAR-NK in 25 ²⁹. Both aim to remove the cost and wait of making a product from each patient's own cells. T-cell engagers, bispecific antibodies such as blinatumomab or teclistamab used at low dose, appear in 17 ³⁰ studies. They are off-the-shelf and need no lymphodepleting chemotherapy. In vivo CAR-T, which programmes T cells inside the body with mRNA or viral vectors, is just entering the clinic.

Lupus, including lupus nephritis, is listed in 147 ¹¹ studies started since 2023. Systemic sclerosis follows with 68 ³¹, then vasculitis (39 ³²), myasthenia gravis (29 ³³), immune cytopenias (26 ³⁴) and multiple sclerosis (25 ³⁵).

The choice of disease reflects both biology and economics. Refractory lupus and systemic sclerosis have high unmet need and clear endpoints, which justifies a one-time, expensive treatment. Myasthenia gravis and multiple sclerosis are larger markets where a cell therapy has to compete with effective antibodies, so safety and convenience matter more there.

No CAR-T or T-cell engager is approved for an autoimmune disease anywhere yet. Only 8 ³ studies in this track are registered as Phase 3. They include Cartesian Therapeutics' mRNA CAR-T Descartes-08 in myasthenia gravis and Bristol Myers Squibb's CD19 CAR-T zola-cel. Industry programmes from Novartis (rapcabtagene autoleucel), Kyverna and Cabaletta Bio have moved beyond first-in-human studies.

Regulators will look closely at long-term safety in patients who, unlike cancer patients, have a normal life expectancy. The risks are secondary malignancy, prolonged cytopenias and infections.

• Autologous CD19 CAR-T is becoming crowded. It has a clear proof of concept, but 195 ¹⁰ studies have started since 2023 and many are in China, so another autologous CD19 product needs a clear edge.
• Value is moving to scalable formats. Allogeneic cells, in vivo CAR-T, conditioning without chemotherapy and T-cell engagers answer the payer question of how to treat millions of patients rather than thousands.
• China offers the fastest proof of concept. Investigator-initiated studies can produce first-in-human data in months. Out-licensing needs data that meets global standards, including durable follow-up and standardised response criteria.
• Pick endpoints that regulators accept. Lupus has established composite endpoints. Systemic sclerosis and vasculitis need careful endpoint strategy early.

Every trial count is the totalCount of one ClinicalTrials.gov API v2 query, retrieved on 26 September 2026. Each numbered citation opens a record whose source link re-runs the query. The track includes interventional studies of CAR-T, CAR-NK or T-cell-engager therapies whose conditions include lupus, systemic sclerosis, myasthenia gravis, multiple sclerosis, myositis, rheumatoid arthritis, vasculitis, NMOSD, Sjogren's disease, immune cytopenias, nephropathies or pemphigus. Studies whose condition field also names a cancer are excluded.

Counts are small, so a few registrations change the picture. Many Chinese investigator-initiated studies are registered only in Chinese registries and are missing. Target and format bars match intervention text and can overlap. The historical background refers to published case reports rather than registry data.