UCAR T-cell Therapy Targeting CD19/BCMA in Patients With r/r Myasthenia Gravis
- Sponsor
- Zhejiang University
- Study ID
- NCT06933563
- Phase
- EARLY_PHASE1
- Status
- Not Yet Recruiting
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Conditions
- Myasthenia Gravis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- UCAR T-cell group — BIOLOGICALA single injection of UCAR T-cells, referred to as universal allogeneic anti-CD19/BCMA CAR T-cells
Study Details
This is an open label, single-site, dose-escalation study in up to 18 participants with relapsed or refractory Myasthenia gravis. This study aims to evaluate the safety and efficacy of the treatment with universal CD19/BCMA CAR T-cells.
Key Dates
- First listed
- Apr 18, 2025
- Start date
- Apr 30, 2025
- Status verified
- Apr 2025
- Primary completion
- Apr 30, 2026
- Completion
- Nov 30, 2027
Study Design
- Enrollment
- 18 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: anti-CD19/BCMA CAR T-cellsUniversal allogeneic CD19/BCMA CAR T-cells
Primary Outcome Measure
The number and severity of dose-limiting toxicity (DLT) events [ Time Frame: Within 28 Days After UCAR T-cell Infusion ]
Central Contacts
- He Huang86-13605714822
- Yongxian Hu86-15957162012
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