Trials / Recruiting
RecruitingNCT07246096
Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
Exploratory Clinical Study on the Safety and Efficacy of Anti-CD19/BCMA Universal CAR-T Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
- Status
- Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Changhai Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA U CAR T cells in patients with autoimmune diseases. 60 patients are planned to be enrolled in the dose-escalation trial.
Conditions
- Autoimmune Diseases
- Systemic Lupus Erythematosus
- Systemic Sclerosis
- Primary Sjögren Syndrome
- Rheumatoid Arthritis
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | anti-CD19/BCMA U CAR T cells | Patients will receive Fludarabine and Cyclophosphamide on day-5, -4, and -3. Dose escalation will be performed for the single dose injection of anti-CD19/BCMA CAR T cells (KN3601) |
Timeline
- Start date
- 2026-02-20
- Primary completion
- 2027-07-20
- Completion
- 2028-07-20
- First posted
- 2025-11-24
- Last updated
- 2026-02-25
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07246096. Inclusion in this directory is not an endorsement.