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 — BIOLOGICAL
    Infusion 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 diseases
    nfusion 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

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