Evaluation of Azercabtagene Zapreleucel in Human Subjects for MS
A Phase 1 interventional study was planned to enroll 100 participants with various forms of multiple sclerosis (MS) to assess the safety of Azercabtagene zapreleucel (azer-cel). The main focus was to track dose-limiting toxicities (DLTs) over a follow-up period extending to 720 days. However, no results from this study have been made available yet.
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- Source
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- Human efficacy
- Not established from this source
- Mechanism
- Not reported
- Evidence strength
- No results yet
- Outcome
- Not reported
Why it matters
Understanding the safety profile of new interventions like azer-cel is crucial for potential future treatments in MS, a group of chronic diseases affecting the central nervous system.
What this does not prove
The current evidence does not include results or outcomes, focusing only on planned enrollment and endpoints without providing any information about the actual findings or safety data.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- 100 · planned enrolment
- Randomised
- No
- Controlled
- Not reported
- Primary endpoint met
- Not reported
- Relevant MS type
- All
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Other
- Biological target
- Not reported
- Pathway
- Not reported
- Population
- Not reported
- Size of effect
- Not reported
- Secondary endpoints
- Not reported
- MRI endpoints
- Not reported
- Biomarkers
- Not reported
- Safety
- Not reported
Original sources
Supporting passages (14)
study phasePhase: Phase 1
study designStudy type: Interventional
subjectsParticipants: people; ages from 18 Years; sex All
sample sizeEnrollment: 100 participants (estimated)
randomizedAllocation: Non randomized
research categoriesB-cell Mediated Autoimmune Disorders
relevant ms typesDiagnosis of primary progressive multiple sclerosis (PPMS), secondary progressive multiple sclerosis (non-active or active), or Relapsing MS (RMS).\n4.
interventionInterventions: Azercabtagene zapreleucel (azer-cel)
primary endpointPrimary endpoints: Number of Participants with Dose-Limiting Toxicities (DLTs)
findingsTrial registry record. Publication date: unknown. No results are posted. Planned enrolment and endpoints are not findings.
limitationsTrial registry record. Publication date: unknown. No results are posted. Planned enrolment and endpoints are not findings.
peer reviewedTrial registry record.
follow upFollow-up: From Day 0 to Day 28; Up to Day 720; Baseline, up to Day 720
sample size basisEnrollment: 100 participants (estimated)
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