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CD19/79b Bi-specific CAR-T Cell Therapy
RECRUITINGPhase 1/2Sponsored by Shenzhen Geno-Immune Medical Institute
Actively Recruiting
PhasePhase 1/2
SponsorShenzhen Geno-Immune Medical Institute
Started2022-06-30
Est. completion2025-12-31
Eligibility
Age6 Months – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05436509
Summary
The purpose of this study is to assess the feasibility, safety and efficacy of CD19/79b bi-specific CAR-T cell therapy in patients with CD19 and/or CD79b positive B cell malignancies. Another goal of the study is to learn more about the safety and function of the anti-CD19/79b bi-specific CAR-T cells and their persistency in patients.
Eligibility
Age: 6 Months – 75 YearsHealthy volunteers accepted
Inclusion Criteria: 1. age older than 6 months. 2. malignant B cell surface expression of CD19 or CD79b molecules. 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 patient 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 CD19 and CD79b 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 1/2
SponsorShenzhen Geno-Immune Medical Institute
Started2022-06-30
Est. completion2025-12-31
Eligibility
Age6 Months – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05436509