Trials / Recruiting
RecruitingNCT07203404
A Study of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.
A Clinical Study of the Safety, Efficacy, and Cell Pharmacokinetics of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.
- Status
- Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
An Exploratory, Single-Arm, Open-Label, Dose-Escalation Study of the Safety, Tolerability, PK, PD, and Efficacy of Anti-CD19/BCMA Universal CAR-T Therapy RD06-05 in Autoimmune Diseases (including SLE/LN, AAV/AAGN, Anti-GBM, MN, SSc, and IIM).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RD06-05 CART Cell Injection | CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide |
Timeline
- Start date
- 2025-07-24
- Primary completion
- 2027-07-23
- Completion
- 2028-07-23
- First posted
- 2025-10-02
- Last updated
- 2025-10-02
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07203404. Inclusion in this directory is not an endorsement.