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RECRUITING
NCT06371040
PHASE1

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

Sponsor: Ting Chang, MD

View on ClinicalTrials.gov

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.

Official title: Evaluate the Safety and Efficacy of CD19-BCMA Targeted CAR-T Therapy for Refractory, Generalized Myasthenia Gravis: A Single-center, Open-label, Single-arm, Dose-finding Study

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2024-07-12

Completion Date

2026-12-01

Last Updated

2025-09-15

Healthy Volunteers

No

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

Locations (1)

Tangdu Hospital, The Fourth Military Medical University

Xi'an, Shaanxi, China