Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Autoimmune Diseases
- Sponsor
- Hebei Senlang Biotechnology Inc., Ltd.
- Study ID
- NCT07161193
- Phase
- PHASE1/PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Autoimmune Diseases
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- CD19 CAR-T cells — BIOLOGICALFollowing lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with CD19 Chimeric Antigen Receptor (CAR) positive T cells as a single dose.
Study Details
The goal of this study is to evaluate the safety and efficacy of CD19 CAR T cells in the treatment of Refractory Autoimmune Diseases
Key Dates
- First listed
- Sep 8, 2025
- Start date
- Sep 30, 2025
- Status verified
- Sep 2025
- Primary completion
- Aug 18, 2027
- Completion
- Nov 18, 2027
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Experimental :CD19 CARFollowing the lymphodepleting treatment, patients will be treated with CD19 Chimeric Antigen Receptor (CAR) positive T cells as a single dose.
Primary Outcome Measure
Phase I:Cytokine Release Syndrome (CRS) [ Time Frame: 28 days post infusion ]
Central Contacts
- Huirui Wang, M.D.+86-0379-63307832
- Songyun Wang, M.D.
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