Trials / Recruiting
RecruitingNCT07339540
the Safety and Efficacy of Targeted BCMA In Vivo LV Injection for Recurrent or Refractory Autoimmune Diseases
Clinical Study on the Safety and Efficacy of Targeted BCMA In Vivo LV Injection in the Treatment of Recurrent or Refractory Autoimmune Diseases
- Status
- Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- Sponsor
- Tongji Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Recurrent or Refractory Systemic Lupus Erythematosus
- Recurrent or Refractory IgG4 Related Diseases
- Recurrent or Refractory Systemic Sclerosis
- Recurrent or Refractory Idiopathic Inflammatory Myopathy
- Recurrent or Refractory ANCA Associated Vasculitis
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-11-04
- Primary completion
- 2028-10-30
- Completion
- 2028-10-30
- First posted
- 2026-01-14
- Last updated
- 2026-01-14
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07339540. Inclusion in this directory is not an endorsement.