CARsgen Administers First Dose of Allogeneic CAR-T Therapy to Patient With Systemic Lupus Erythematosus

February 2026 — Global Biotech News

Shanghai, China / Global — CARsgen Therapeutics Holdings Ltd., a clinical-stage biotechnology company focused on innovative chimeric antigen receptor T-cell (CAR-T) therapies, announced that its allogeneic CAR-T candidate KJ-C2219 has been administered to the first patient with systemic lupus erythematosus (SLE) in an investigator-initiated clinical trial.

KJ-C2219 is an allogeneic (donor-derived) CAR-T therapy engineered to target CD19/CD20, antigens implicated in pathogenic B-cell activity. The therapy is being evaluated in systemic lupus erythematosus — an autoimmune disease in which the body’s immune system attacks healthy tissue, leading to widespread inflammation and organ damage.

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Unlike conventional CAR-T therapies that are manufactured individually using a patient’s own cells, allogeneic CAR-T products like KJ-C2219 are produced from healthy donor cells, potentially enabling off-the-shelf availability and broader clinical applicability. This administration to a lupus patient marks one of the earliest reported uses of an allogeneic CAR-T therapy in autoimmune disease outside oncology.

The trial is investigator-initiated, with researchers following a predefined protocol to evaluate safety, tolerability and early signs of clinical benefit. Early clinical experience in autoimmune settings remains limited relative to cancer indications, so this dosing milestone is being closely watched by clinicians and investors alike.

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“This first dosing in lupus reflects the growing interest in extending CAR-T approaches beyond hematologic malignancies into autoimmune disorders,” said a biotechnology analyst following CAR-T development trends. “If safety and efficacy are demonstrated, allogeneic CAR-T could address significant unmet needs in autoimmune disease.”

Source: CARsgen’s Allogeneic CD19/CD20 CAR-T Therapy Administers First Dose in a Patient With Autoimmune Disease — PR Newswire / CARsgen Therapeutics (February 2025 reporting)