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4SCAR19U T Cells Targeting B Cell Malignancies
RECRUITINGPhase 1Sponsored by Shenzhen Geno-Immune Medical Institute
Actively Recruiting
PhasePhase 1
SponsorShenzhen Geno-Immune Medical Institute
Started2023-10-31
Est. completion2026-09-30
Eligibility
Age6 Months – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05995015
Summary
The purpose of this study is to assess the feasibility, safety and efficacy of universal CAR T cell therapy against CD19-positive hematological malignancies using a novel CD19-specific CAR T cell product, 4SCAR19U T cells. The study also aims to learn more about the function of the 4SCAR19U T cells and their persistence in patients. This is a phase I trial enrolling patients from multiple clinical centers.
Eligibility
Age: 6 Months – 75 YearsHealthy volunteers accepted
Inclusion Criteria: 1. Age older than 6 months. 2. Primary B cell surface expression of CD19. 3. The KPS score over 80 points, and survival time is more than 1 month. 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 response after treatment. 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.
Conditions2
B-cell MalignanciesCancer
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
PhasePhase 1
SponsorShenzhen Geno-Immune Medical Institute
Started2023-10-31
Est. completion2026-09-30
Eligibility
Age6 Months – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05995015