Clinical Scorecard: BMS Details Patient Death in Zola-Cel Multiple Sclerosis Trial
At a Glance
| Category | Detail |
|---|---|
| Condition | Multiple sclerosis (MS), including highly active relapsing or progressive disease |
| Key Mechanisms | Zolacabtagene autoleucel (zola-cel) is an investigational autologous CD19-directed CAR T-cell therapy intended to deplete CD19-positive B cells and allow the immune system to repopulate with new B cells. |
| Target Population | People with highly active relapsing or progressive MS that continued to worsen despite treatment, enrolled in a Phase I dose-escalation study. |
| Care Setting | Phase I clinical trial. |
Key Highlights
- BMS reported a patient death 44 days after zola-cel infusion. The patient developed delayed motor symptoms, received high-dose cyclophosphamide, developed septic pneumonia, and died the following day.
- The delayed motor symptoms were not classified as ICANS and did not resolve after intermittent corticosteroids and intravenous immunoglobulin.
- Cytokine release syndrome occurred in 28 of 66 participants: 24 grade 1 and four grade 2; the median time to resolution was two days.
- Five participants developed ICANS, including one grade 4 event in a participant with progressive MS; it resolved within four days after corticosteroids and anakinra.
- Among participants with at least 26 weeks of follow-up, six of seven evaluable patients with highly active relapsing MS had no relapses, disability progression, or new MRI activity.
Guideline-Based Recommendations
Diagnosis
Management
Monitoring & Follow-up
Risks
Patient & Prescribing Data
The Phase I dose-escalation study enrolled 66 people with highly active relapsing or progressive MS that continued to worsen despite treatment. The article describes zola-cel as investigational.
All 60 patients treated at the second dose level remained off disease-modifying therapies at their latest assessment, including nine followed for more than one year. These are interim trial findings.
Clinical Best Practices
Related Resources & Content
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