Novartis halts eight CAR T cell therapy trials following three deaths

Novartis has halted eight clinical trials of an experimental CAR T cell therapy following three deaths linked to severe immune reactions. The pause affects studies targeting various autoimmune and neurological disorders, including systemic lupus erythematosus, lupus nephritis, systemic sclerosis, rheumatoid arthritis, and multiple sclerosis.

The fatal reactions were identified as immune effector cell-associated hemophagocytic syndrome (IEC-HS), a condition where the body’s immune system attacks its own organs. Novartis is conducting a comprehensive review alongside independent safety boards to examine the events and determine if methods exist to detect these dangerous side effects earlier.

Bristol Myers Squibb has also paused enrollment in a parallel autoimmune program. While the autoimmune and neurological trials are suspended, Novartis confirmed that its oncology programs using the same therapy for leukemia and lymphoma remain unaffected and will continue as planned.