RecruitingPhase 1Phase 2NCT05459870

CAR-T Cells Targeting Autoimmune Diseases

CAR-T Cells Targeting B Cell Related Autoimmune Diseases


Sponsor

Shenzhen Geno-Immune Medical Institute

Enrollment

30 participants

Start Date

Jul 31, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to assess the feasibility, safety and efficacy of CAR-T cell therapy in patients with autoimmune disease. Another goal of the study is to learn more about the safety and function of the CAR-T cells and their persistency in autoimmune disease patients.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

  • age older than 18 years.
  • expression of B cell surface molecules.
  • 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

BIOLOGICAL4SCAR T cells

Infusion of 4SCAR T cells at 10\^6 cells/kg body weight via IV


Locations(2)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, China

Guilin Hospital of Chinese Traditional and Western Medicine

Guilin, Guangxi, China

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NCT05459870


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