Novartis pauses autoimmune cell therapy trials after three patient deaths

Novartis AG temporarily paused eight clinical trials of its experimental CAR-T therapy, rapcabtagene autoleucel, in late August 2026 after three patients died from severe immune responses. The trials were evaluating the CD19-directed treatment for autoimmune and neurological disorders. Novartis is reviewing the safety events alongside independent boards and regulators, while Bristol Myers Squibb has also paused similar trials as a precaution.

Novartis CAR-T trial suspension

• ▪Novartis AG is sharing information regarding the clinical trial safety events and patient deaths with regulatory authorities
• ▪Bristol Myers Squibb paused clinical trials of its own CAR-T treatment for autoimmune disorders as a precautionary measure
• ▪Novartis AG stopped enrolling and treating new patients in the rapcabtagene autoleucel trials while conducting a safety review of the observed events
• ▪The paused Novartis AG clinical trials were evaluating the experimental cell therapy for the treatment of autoimmune and neurological disorders
• ▪Novartis AG is working with independent safety boards overseeing each of the paused clinical trials
• ▪Novartis AG temporarily paused eight clinical trials of its experimental CAR-T therapy, rapcabtagene autoleucel (also known as rap-cel or YTB323), in late August 2026

Patient deaths from immune response

• ▪Three patients died in the Novartis AG clinical trials after experiencing a severe, dangerous immune system response
• ▪Novartis AG described the fatal severe immune response observed in the trials as a known safety risk associated with CAR-T therapies

CAR-T therapy mechanism

• ▪Chimeric antigen receptor T-cell (CAR-T) therapies modify a patient's own immune cells to recognize a specific target and destroy cancer cells
• ▪The experimental Novartis AG CAR-T treatment, rapcabtagene autoleucel, is a CD19-directed therapy

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