Trials / Recruiting
RecruitingNCT06548607
Clinical Study on Targeted CD19 or CD19-BCMA CAR-T Therapy for Autoimmune Diseases
- Status
- Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CD19 or CD19-BCMA CAR-T in patients with active SLE, SSc, AAV, IIM and pSS.
Conditions
- SLE (Systemic Lupus)
- Systemic Sclerosis
- ANCA Associated Vasculitis
- Idiopathic Inflammatory Myopathies
- Sjogren's Syndrome
- Autoimmune Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CD19 or CD19-BCMA CAR-T | CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide. |
Timeline
- Start date
- 2024-09-14
- Primary completion
- 2026-12-31
- Completion
- 2027-12-31
- First posted
- 2024-08-12
- Last updated
- 2026-03-06
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06548607. Inclusion in this directory is not an endorsement.