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Clinical Trials in China / NCT06435897
Starting soon Phase 1/2

Autoimmune Disease Treatment With Mesenchymal Stem Cells (MSCs) and CAR-T Cells

NCT06435897 · tracked via the Priya Life Science China tracker
Sponsor
Shenzhen Geno-Immune Medical Institute
Phase
Phase 1/2
Started
2027-06-30
Last updated
2026-11-02

Condition(s) studied

Autoimmune Diseases

Investigational drug(s) / intervention(s)

fetal MSCs combined with 4SCAR T cells

fetal MSCs combined with 4SCAR T cells: Infusion of 4SCAR T cells at 10\^6 cells/kg body weight and MSCs at 3x10\^6 cells via IV

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. older than 18 years of age. 2. established autoimmune conditions. 3. the KPS score over 80 points, and survival time is more than 3 months. 4. greater than Hgb 80 g/L. 5. no contraindications to blood cell collection. Exclusion Criteria: 1. accompanied with other active diseases and difficult to assess treatment response. 2. bacterial, fungal, or viral infection, unable to control. 3. living with HIV. 4. active HBV or HCV infection. 5. pregnant and nursing mothers. 6. under systemic steroid treatment within a week of the treatment. 7. prior failed CAR-T treatment.

Primary outcome measure(s)

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. — 1 month
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
  • Safety of 4SCAR T cells in patients with autoimmune diseases using CTCAE 5 standard to evaluate the level of adverse events — 12 week
    Safety of 4SCAR T cells in patients with autoimmune diseases using CTCAE 5 standard to evaluate the level of adverse events with measuring cytokine response

Trial sites (1)

FacilityCityRegionStatus
Shenzhen Geno-immune Medical Institute Shenzhen Guangdong

More Shenzhen Geno-Immune Medical Institute trials in China

Engineered Dendritic Cell Vaccines for Multiple Myeloma Starting soon
cfMSC Therapy for Diabetes Starting soon
Lentiviral FVIII Gene Therapy Starting soon
Multi-CAR-T Cells Targeting B Cell Lymphomas Starting soon
PSMA-specific CAR-T Cell Therapy Starting soon

Other trials for the same condition

Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement Recruiting
Anti CD19/BCMA CAR Gene Therapy for Autoimmune Diseases Recruiting
Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Autoimmune Diseases Recruiting
Exploratory Clinical Study of Second-generation CD19/BCMA Chimeric Antigen Receptor NK Cell Injection in Treating Paediatric B Cell-related Autoimmune Diseases Recruiting
Safety and Efficacy of KSVCBD Injection in Autoimmune Diseases Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06435897 on ClinicalTrials.gov ↗ ← All trials in China