Autoimmune Disease Treatment With Mesenchymal Stem Cells (MSCs) and CAR-T Cells
- Sponsor
- Shenzhen Geno-Immune Medical Institute
- Study ID
- NCT06435897
- Phase
- PHASE1/PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Autoimmune Diseases
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- fetal MSCs combined with 4SCAR T cells — BIOLOGICALInfusion of 4SCAR T cells at 10\^6 cells/kg body weight and MSCs at 3x10\^6 cells via IV
Study Details
The purpose of this study is to assess the feasibility, safety and efficacy of mesenchymal stem cells (MSCs) in combination with CAR-T cells in treating autoimmune disease. Another goal of the study is to learn more about the safety and function of the MSCs combined with CAR-T cells and their long term effects in autoimmune disease patients.
Key Dates
- First listed
- May 30, 2024
- Start date
- Jun 30, 2027
- Status verified
- Aug 2026
- Primary completion
- Dec 31, 2028
- Completion
- Dec 31, 2029
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: MSC combined with 4SCAR T-cell therapy for autoimmune diseasesnfusion of 4SCAR T cells at 10\^6 cells/kg body weight and MSCs at 3x10\^6 cells via IV
Primary Outcome Measure
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. [ Time Frame: 1 month ]
Central Contacts
- Lung-Ji Chang, PhD+86 0755-86573763
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