Novartis and BMS Pause Autoimmune CAR T Trials Over Safety Concerns
Three deaths linked to immune effector cell-associated hemophagocytic syndrome prompt Novartis to halt eight rap-cel studies
Clinical Scorecard: Novartis and BMS Pause Autoimmune CAR T Trials Over Safety Concerns
At a Glance
Category Detail
Condition Autoimmune diseases Key Mechanisms CD19-directed CAR T therapies Target Population Patients with autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, and others Care Setting Clinical trials
Key Highlights
Novartis paused eight studies of rapcabtagene autoleucel after three patients developed IEC-HS. All three patients with IEC-HS complications died. Bristol Myers Squibb paused enrollment in trials of zolacabtagene autoleucel due to safety monitoring findings. IEC-HS is a known risk associated with CAR T treatments. Patients already treated will continue to be monitored. Guideline-Based Recommendations
Diagnosis
Monitor for signs of IEC-HS in patients receiving CAR T therapies. Management
Pause trials and review safety data when serious adverse events occur. Monitoring & Follow-up
Implement routine safety monitoring during clinical trials. Risks
Be aware of the potential for life-threatening reactions such as IEC-HS. Patient & Prescribing Data
Patients with autoimmune diseases participating in clinical trials.
Both therapies are autologous CAR T treatments with known risks.
Clinical Best Practices
Engage independent safety boards for review of adverse events. Ensure ongoing monitoring of patients already treated in paused trials. Related Resources & Content
