Novartis, Bristol Myers Squibb pause CAR-T trials for lupus and other autoimmune diseases for safety reviews

Novartis and Bristol Myers Squibb have paused their clinical trials studying their respective CAR-T cell therapies for lupus and other autoimmune diseases while they review safety findings. Novartis placed holds on trials of rap-cel, stopping screening, randomization, and treatment administration, after three study participants experienced a rare, potentially life-threatening inflammatory reaction known as immune effector cell-associated hemophagocytic syndrome (IEC-HS) and later died from complications. Bristol Myers Squibb separately paused enrollment in trials of zola-cel after observing what the company described as transient and reversible inflammatory events.

Novartis initiated the holds on August 24 across studies of rap-cel in lupus, myasthenia gravis, multiple sclerosis and other autoimmune conditions and is reviewing the clinical and safety data with regulators. Bristol Myers Squibb said it voluntarily paused enrollment in autoimmune trials of zola-cel as a precaution while it reviews data across the program. The company previously reported one case of IEC-HS in a Phase 1 study of zola-cel and said it continues to have confidence in the therapy, including responses observed among people with systemic lupus erythematosus.

These trial pauses underscore the importance of continued research and vigilance to evaluate both the potential benefits and safety of CAR-T cell therapies for lupus. 

Learn More