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RECRUITING
NCT07339540
EARLY_PHASE1

the Safety and Efficacy of Targeted BCMA In Vivo LV Injection for Recurrent or Refractory Autoimmune Diseases

Sponsor: Tongji Hospital

View on ClinicalTrials.gov

Summary

This study is designed as a single arm, open label, single center clinical trial to evaluate the safety, tolerability, efficacy, pharmacokinetic or pharmacodynamic characteristics of the investigational drug V001-BCMA in autoimmune disease.

Official title: Clinical Study on the Safety and Efficacy of Targeted BCMA In Vivo LV Injection in the Treatment of Recurrent or Refractory Autoimmune Diseases

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2025-11-04

Completion Date

2028-10-30

Last Updated

2026-01-14

Healthy Volunteers

No

Interventions

DRUG

V001-BCMA

Targeted BCMA In-vivo LV Injection (Code: V001-BCMA) is a third-generation non-replicating self-inactivating lentiviral vector. Its envelope protein has been engineered to express targeting molecules on the lentiviral surface for specific recognition of T cells, while its nucleic acid contains a T cell-specific promoter and a CAR gene. After specifically targeting and binding to T cells, V001-BCMA enables the expression of CAR on the surface of T cells, forming CAR-T cells. These CAR-T cells can then specifically kill target cells.

Locations (1)

Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China