Trials / Suspended
SuspendedNCT06549296
Clinical Study on Targeted CD19CAR-T Therapy for Autoimmune Diseases
Clinical Study on the Safety, Efficacy, and Pharmacokinetics of CAR-T Cell Injection Targeting CD19 in the Treatment of Patients With Active Autoimmune Diseases
- Status
- Suspended
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, investigator-initiated clinical trial (IIT) aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with active SLE, SSc, AAV, IIM, and pSS
Conditions
- Systemic Lupus Erythematosus
- Systemic Sclerosis
- ANCA Associated Vasculitis
- Idiopathic Inflammatory Myopathies
- Sjogren's Syndrome
- Autoimmune Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RD06-04 CART Cell Injection | CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide. |
Timeline
- Start date
- 2024-09-13
- Primary completion
- 2026-08-01
- Completion
- 2027-08-01
- First posted
- 2024-08-12
- Last updated
- 2026-02-03
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06549296. Inclusion in this directory is not an endorsement.