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 — BIOLOGICAL
    A 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-cells
    Universal 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

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