Trials / Recruiting
RecruitingNCT06056921
Safety and Efficacy of CD19 Targeted CAR-T Therapy for Refractory Autoimmune Disease
Clinical Study of CD19 Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of Refractory Autoimmune Diseases
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- Chongqing Precision Biotech Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a single arm study to evaluate the efficacy and safety of CD19 targeted CAR-T cells therapy for patients with Refractory Autoimmune Disease
Detailed description
the CD19 targeted CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell Leukemia and Lymphoma. Otherwise, some studies have shown that the use of CD19-targeted CAR-T therapy in refractory SLE can improve the autoimmune symptoms of patients, and at the same time, immunosuppressants and hormones can be stopped to maintain long-term autoimmune indicators normal.To verify the safety and efficacy, the investigators launch such a clinical trial using CD19 targeted CAR-T cells for patients with Refractory Autoimmune Disease.
Conditions
- SLE (Systemic Lupus)
- Sjogren's Syndrome
- Systemic Scleroderma
- Dermatomyositis
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CD19 targeted CAR-T cells | A single infusion of CD19 CAR-T cells will be administered intravenously |
Timeline
- Start date
- 2023-08-31
- Primary completion
- 2025-12-31
- Completion
- 2026-08-31
- First posted
- 2023-09-28
- Last updated
- 2023-09-28
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06056921. Inclusion in this directory is not an endorsement.