RecruitingPhase 1Phase 2NCT05436496
CD19/70 Bi-specific CAR-T Cell Therapy
CD19/70 Bi-specific CAR-T Cells Targeting B Cell Malignancies
Sponsor
Shenzhen Geno-Immune Medical Institute
Enrollment
30 participants
Start Date
Jun 30, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to assess the feasibility, safety and efficacy of CD19/70 bi-specific CAR-T cell therapy in patients with CD19 and/or CD70 positive B cell malignancies. Another goal of the study is to learn more about the safety and function of the anti-CD19/70 bi-specific CAR-T cells and their persistency in patients.
Eligibility
Min Age: 6 MonthsMax Age: 75 Years
Inclusion Criteria5
- age older than 6 months.
- malignant B cell surface expression of CD19 or CD70 molecules.
- the KPS score over 80 points, and survival time is more than 1 month.
- greater than Hgb 80 g/L.
- no contraindications to blood cell collection.
Exclusion Criteria7
- accompanied with other active diseases and difficult to assess patient 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 CD19 and CD70 CAR-T treatment.
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Interventions
BIOLOGICALbi-4SCAR CD19/70 T cells
Infusion of bi-4SCAR CD19/70 T cells at 10\^6 cells/kg body weight via IV
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05436496
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