Clinical Report: Novartis and BMS Pause Autoimmune CAR T Trials Over Safety Concerns

Overview

Novartis and Bristol Myers Squibb have paused clinical trials of their CD19-directed CAR T therapies in autoimmune diseases due to safety concerns related to immune effector cell-associated hemophagocytic syndrome (IEC-HS). This decision follows the deaths of three patients in Novartis' trials.

Background

The use of CAR T-cell therapies has expanded beyond oncology into autoimmune diseases, presenting new therapeutic options but also significant safety challenges. IEC-HS is a severe inflammatory reaction associated with these therapies, which can lead to fatal outcomes.

Data Highlights

No numerical data or trial results were provided in the source material.

Key Findings

• Novartis paused eight studies of rapcabtagene autoleucel (rap-cel) after three patients developed IEC-HS, leading to fatalities.
• Bristol Myers Squibb paused enrollment in trials of zolacabtagene autoleucel (zola-cel) due to observed inflammatory events during safety monitoring.
• IEC-HS is recognized as a potentially life-threatening risk associated with CAR T treatments.
• Both companies are collaborating with independent safety boards and health authorities to review the safety data.
• Oncology studies of rap-cel in leukemia and lymphoma remain unaffected by the pause.

Clinical Implications

The pauses in these trials highlight the serious risks associated with CAR T therapies, particularly IEC-HS.

Conclusion

The temporary halts in CAR T trials by Novartis and Bristol Myers Squibb reflect ongoing safety evaluations in the development of therapies for autoimmune diseases.

Related Resources & Content

1. Novartis, Bristol Myers pause autoimmune CAR-T trials due to safety concerns | BioPharma Dive
2. ASTCT Consensus Grading for Toxicities after Immune Effector Cell Therapy - Transplantation and Cellular Therapy
3. What’s Happening with CAR T Therapies? | The Medicine Maker
4. Lupus Treatment Trial Paused Following Patient Deaths | Reuters
5. Clinical Outcomes, Contributing Factors, and Management Approaches for Late-Onset Neurotoxicities Associated with Ciltacabtagene Autoleucel CAR-T Therapy in Multiple Myeloma Patients | Blood Cancer Journal
6. The ASCO Post — CAR T-Cell Therapy Makes Further Inroads in Lymphoma and Myeloma
7. Novartis, Bristol Myers pause autoimmune CAR-T trials due to safety concerns | BioPharma Dive
8. ASTCT Consensus Grading for Toxicities after Immune Effector Cell Therapy - Transplantation and Cellular Therapy, Official Publication of the American Society for Transplantation and Cellular Therapy
9. CD19 CAR-T cells for treatment-refractory autoimmune diseases: the phase 1/2 CASTLE basket trial | Nature Medicine