Bristol-Myers Squibb Company (BMY)

Novartis and Bristol Myers Squibb have temporarily halted their clinical trials for CAR-T cell therapies in lupus and other autoimmune diseases to conduct safety reviews. Novartis paused trials after three participants in rap-cel studies died from complications of a rare inflammatory reaction. Bristol Myers Squibb voluntarily paused enrollment in zola-cel trials as a precaution after observing transient inflammatory events, though the company maintains confidence in the therapy.

Novartis has suspended multiple studies for its CAR T candidate, rapcabtagene autoleucel, after three patients died from severe immune effector cell-associated hemophagocytic syndrome (IEC-HS). Concurrently, Bristol Myers Squibb has voluntarily paused some autoimmune trials for its CAR T asset, zolacabtagene autoleucel, due to observed "transient and reversible inflammatory events," although no deaths were reported. Both companies are reviewing clinical data and engaging with independent committees to address the safety concerns and determine next steps.

Novartis has halted eight clinical trials for its experimental CAR-T gene therapy targeting autoimmune and neurological disorders after three patient deaths due to immune effector cell-associated hemophagocytic syndrome (IEC-HS). Concurrently, Bristol Myers Squibb (BMS) paused enrollment in its own autoimmune CAR-T therapy trials due to similar immune-related adverse events. Analysts suggest that the rapid manufacturing technologies used by both companies, intended to speed up production, might be contributing to the observed toxicities.

Novartis and Bristol Myers Squibb have temporarily halted their respective CAR-T cell therapy trials for autoimmune conditions due to safety concerns. Novartis's rap-cel program experienced three fatal cases of immune effector cell-associated hemophagocytic syndrome, while Bristol Myers' zolacabtagene autoleucel (zola-cel) trials noted "transient and reversible inflammatory events." Both companies are reviewing the clinical and safety data to determine the future of their programs, which aim to repurpose cancer cell therapies for autoimmune diseases.

Novartis has halted its autoimmune CAR-T therapy trials following three patient deaths due to severe immune effector cell-associated hemophagocytic syndrome (IEC-HS). Concurrently, Bristol Myers Squibb also paused its similar CAR-T program due to "transient and reversible inflammatory events." Both companies' candidates use rapid manufacturing platforms, leading analysts to suggest a potential link between this technology and the observed toxicities.