Researchers found that Novartis and Bristol Myers Squibb have paused their clinical trials for CAR-T cell therapies aimed at treating autoimmune diseases due to serious safety concerns. Specifically, Novartis halted its CD19 CAR-T candidate, rapcabtagene autoleucel (rap-cel), after three deaths were linked to a severe inflammatory condition known as immune effector cell-associated hemophagocytic syndrome (IEC-HS). This decision affects various trials for conditions such as lupus, rheumatoid arthritis, and multiple sclerosis. Bristol Myers Squibb also paused its similar treatment, zola-cel, due to related inflammatory events.

This development is significant for people interested in innovative treatments for autoimmune diseases. CAR-T therapies aim to reprogram a patient's own immune cells to target and eliminate disease-causing cells. However, the recent pause raises questions about the safety of these therapies. For those considering such treatments, this news highlights the importance of understanding potential risks and the ongoing evaluation of new therapies before they become widely available.

The evidence shows that these trials are in the early to mid-stages of development, with Novartis's trials being in phase 1 and 2. The pause allows for a thorough review of the safety data following the serious adverse events. While CAR-T therapies have shown promise in oncology, their application in autoimmune diseases is still being explored, and the current findings warrant caution.

If you are considering CAR-T therapy for autoimmune conditions, it's essential to stay informed about ongoing research and safety evaluations. Discuss any concerns with your healthcare provider, as they can provide guidance based on the latest developments and your specific health needs.

References:

  • Novartis and Bristol Myers Squibb halt CAR-T cell trials due to immune events, Fierce Biotech.