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NCT05459870
CAR-T Cells Targeting Autoimmune Diseases
Conditions: Autoimmune Diseases
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 30
Sponsor: Shenzhen Geno-Immune Medical Institute
Location: Shenzhen Geno-immune Medical Institute Shenzhen Guangdong
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 Criteria
Inclusion Criteria:
1. age older than 18 years.
2. expression of B cell surface molecules.
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.
Source: ClinicalTrials.gov (NCT05459870). StuddyBuddy aggregates publicly available trial information.
