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.
