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

NCT06371040 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-09-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

CD19-BCMA Targeted CAR-T Dose 1

5.0 e5/ kg CD19-BCMA CAR-T positive T cells

DRUG

CD19-BCMA Targeted CAR-T Dose 2

1.5 e6/ kg CD19-BCMA CAR-T positive T cells

DRUG

CD19-BCMA Targeted CAR-T Dose 2

5 e6/ kg CD19-BCMA CAR-T positive T cells

Sponsors & Collaborators

  • Ting Chang, MD

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-12
Primary Completion
2025-11-01
Completion
2026-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06371040 on ClinicalTrials.gov