CAR-T Cells Therapy for Patients With Autoimmune Diseases
- Sponsor
- Anhui Provincial Hospital
- Study ID
- NCT07052565
- Status
- Recruiting
Conditions
- Autoimmune Diseases
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis — DRUGA single intravenous infusion of anti-BCMA and CD19 CART cells (dose-escalating infusion of 1.0-6.0 x10\^5 CART cells/kg)
Study Details
This is an open label, single-site, dose-escalation study in up to 18 participants with refractory autoimmune diseases. This study aims to evaluate the safety and efficacy of the treatment with Anti-BCMA and CD19 CART
Key Dates
- First listed
- Jul 4, 2025
- Start date
- Jul 20, 2025
- Status verified
- Jun 2025
- Primary completion
- Nov 1, 2028
- Completion
- Nov 1, 2028
Study Design
- Enrollment
- 18 participants (estimated)
- Allocation
- NA
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Anti-BCMA and CD19 CARTPatients will receive a lymphodepletion chemotherapy with cyclophosphamide and fludarabine before CART infusion. A dose of Anti-BCMA and CD19 CART will be infused on day 0.
Primary Outcome Measure
Adverse events [ Time Frame: up to 1 years ]
Central Contacts
- chen zhu, M.D+86-0551-62283843
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