Safety and Efficacy of CD19-BCMA Targeted CAR-T Therapy for Refractory Generalized Myasthenia Gravis

Sponsor
Ting Chang, MD
Study ID
NCT06371040
Phase
PHASE1
Status
Recruiting
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Conditions

  • Myasthenia Gravis

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • CD19-BCMA Targeted CAR-T Dose 1 — DRUG
    5.0 e5/ kg CD19-BCMA CAR-T positive T cells
  • CD19-BCMA Targeted CAR-T Dose 2 — DRUG
    1.5 e6/ kg CD19-BCMA CAR-T positive T cells
  • CD19-BCMA Targeted CAR-T Dose 2 — DRUG
    5 e6/ kg CD19-BCMA CAR-T positive T cells

Study Details

This study is a single-center, open-label, single-arm, dose-exploration study to evaluate the safety and preliminary effectiveness of CD19-BCMA CAR-T in the treatment of refractory, generalized myasthenia gravis. The study is a dose escalation trial in adult, refractory, systemic MG patients. The Keyboard method will be used to perform dose escalation to explore the maximum tolerated dose (MTD). A total of 12 MG patients who meet the inclusion criteria are expected to be recruited.

Key Dates

First listed
Apr 17, 2024
Start date
Jul 12, 2024
Status verified
Sep 2025
Primary completion
Nov 1, 2025
Completion
Dec 1, 2026

Study Design

Enrollment
9 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: CD19-BCMA Targeted CAR-T

Primary Outcome Measure

Frequency, type, and severity of adverse events [ Time Frame: From Baseline (Day 1) to Safety Follow-Up Visit (up to 4 weeks) ]

Central Contacts

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