RecruitingPhase 1Phase 2NCT06435897

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

Management of Autoimmune Conditions With Mesenchymal Stem Cells (MSCs) and CAR-T Cells


Sponsor

Shenzhen Geno-Immune Medical Institute

Enrollment

30 participants

Start Date

May 15, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

  • older than 18 years of age.
  • established autoimmune conditions.
  • the KPS score over 80 points, and survival time is more than 3 months.
  • greater than Hgb 80 g/L.
  • no contraindications to blood cell collection.

Exclusion Criteria7

  • accompanied with other active diseases and difficult to assess treatment response.
  • bacterial, fungal, or viral infection, unable to control.
  • living with HIV.
  • active HBV or HCV infection.
  • pregnant and nursing mothers.
  • under systemic steroid treatment within a week of the treatment.
  • prior failed CAR-T treatment.

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Interventions

BIOLOGICALfetal 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


Locations(1)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, China

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NCT06435897


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