NCT06371040

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

Recruiting now Phase 1 Last updated 15 September 2025

What this trial tests

Phase 1 trial testing CD19-BCMA Targeted CAR-T Dose 1 in Myasthenia Gravis in 9 participants. Currently enrolling.

Timeline

12 July 2024

Primary endpoint
1 November 2025

1 December 2026

Quick facts

Lead sponsor	Ting Chang, MD
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	12 July 2024
Primary completion	1 November 2025
Estimated completion	1 December 2026
Sites	1 location across China

Drugs / interventions tested

• CD19-BCMA Targeted CAR-T Dose 1 — full drug profile →
• CD19-BCMA Targeted CAR-T Dose 2
• CD19-BCMA Targeted CAR-T Dose 2

Conditions studied

• Myasthenia Gravis — all drugs for Myasthenia Gravis →

Sponsor

Ting Chang, MD — full company profile →

Who can join

Adults 18 to 80, any sex, with Myasthenia Gravis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Application of novel CAR technologies to improve treatment of autoimmune disease.
   Cheever A, Kang CC, O'Neill KL, Weber KS. · · 2024 · cited 18× · PMID 39445021 · DOI 10.3389/fimmu.2024.1465191
2. CAR immunotherapy in autoimmune diseases: promises and challenges.
   Yu J, Yang Y, Gu Z, Shi M, et al · · 2024 · cited 13× · PMID 39411714 · DOI 10.3389/fimmu.2024.1461102
3. CAR T-cell therapy in autoimmune diseases: a promising frontier on the horizon.
   Wu D, Xu-Monette ZY, Zhou J, Yang K, et al · · 2025 · cited 9× · PMID 40873568 · DOI 10.3389/fimmu.2025.1613878
4. Challenges and strategies in clinical applications of CAR-T therapy for autoimmune diseases.
   Chen X, Liu K, Liu B, Li S, et al · · 2025 · cited 4× · PMID 41316450 · DOI 10.1186/s13045-025-01769-0
5. Innovations in immunotherapy for autoimmune diseases: recent breakthroughs and future directions.
   Alsayb MA. · · 2025 · cited 2× · PMID 41041324 · DOI 10.3389/fimmu.2025.1647066
6. Research progress on chimeric antigen receptor-based immunotherapy against autoimmune diseases.
   Jiang M, Zhao J, Yuan J, Yu Z, et al · · 2025 · cited 2× · PMID 40747591 · DOI 10.1080/21645515.2025.2538350
7. CD19-directed chimeric antigen receptor T-cell therapy: what can we learn from the haematologist?
   Kuipers MT, Kersten MJ. · · 2025 · cited 2× · PMID 39832905 · DOI 10.1136/lupus-2024-001157
8. Roads and detours for CAR T cell therapy in autoimmune diseases.
   Avouac J, Barzel A, Caiati D, Davis RS, et al · · 2026 · cited 1× · PMID 41588112 · DOI 10.1038/s41573-025-01349-4