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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05459870
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