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Eque-cel in Refractory Immune-mediated Necrotizing Myopathy
NCT07752264Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Aug 2026
- Primary completion
- Aug 2030
- Countries
- 1
- Sponsor
- Reindeer Biotech
- Conditions
- Immune-mediated necrotizing myopathy (IMNM)
01
Overview
Phase 2, open-label, single-arm trial of equecabtagene autoleucel in Immune-mediated necrotizing myopathy (IMNM), sponsored by Reindeer Biotech. Primary endpoints: Adverse Events up to 2 years, Dose-limiting toxicity up to 28 days and 1 more. Planned start Aug 2026; status: not yet recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Equecabtagene Autoleucel Injection（Eque-cel）
Single intravenous infusion of Eque-cel Injection
03
Who it enrols
Adults with refractory IMNM positive for anti-SRP or anti-HMGCR antibodies, who failed standard treatment. Excludes patients with severe organ involvement, active infections, prior BCMA-targeted therapy, or prior stem cell transplant.
04
Endpoints
Primary
Adverse Events
Dose-limiting toxicity
Total Improvement Score response
Secondary
Proportion of participants achieving minimal improvement response (TIS ≥ 20 points)
Change in mean Total Improvement Score value
Patient Global Assessment scores
Physician Global Assessment scores
Manual Muscle Testing-8
Health Assessment Questionnaire Scale
Creatine Kinase
Myositis Disease Activity Assessment Tool scores
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