Trials / Recruiting
RecruitingNCT06614270
Anti-CD19 IL-10/IL15 CAR-NK Cells in Refractory/Relapsed Autoimmune Diseases
Clinical Study of Core Blood-derived Anti-CD19 IL-10/IL15 CAR-NK in the Treatment of Refractory/Relapsed Autoimmune Diseases
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study is a single-center, open-label, single-arm, dose-escalation trial. The aim of this study is to investigate the safety and efficacy of Anti-CD19 IL-10/IL15 CAR-NK cells in patients with refractory/relapsed autoimmune diseases, including systemic lupus erythematosus, systemic sclerosis, idiopathic inflammatory myositis, ANCA associated vasculitis, sjogren syndrome, and antiphospholipid syndrome.
Conditions
- Systemic Sclerosis (SSc)
- ANCA Associated Vasculitis (AAV)
- Idiopathic Inflammatory Myopathy (IIM)
- Sjogren's Syndrome
- Antiphospholipid Syndrome
- Systemic Lupus Erythematosus
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Anti-CD19 IL-10/IL15 CAR-NK | Patients will receive Fludarabine and Cyclophosphamide for conditioning. Multiple doses of Anti-CD19 IL-10/IL15 CAR-NK cells will be infused on Day 0, 3, and 6. |
Timeline
- Start date
- 2025-01-06
- Primary completion
- 2026-01-06
- Completion
- 2027-01-06
- First posted
- 2024-09-26
- Last updated
- 2025-12-29
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06614270. Inclusion in this directory is not an endorsement.