CD19/79b Bi-specific CAR-T Cell Therapy
CD19/79b Bi-specific CAR-T Cells Targeting B Cell Malignancies
Shenzhen Geno-Immune Medical Institute
60 participants
Jun 30, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- age older than 6 months.
- malignant B cell surface expression of CD19 or CD79b 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 CD79b CAR-T treatment.
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Interventions
Infusion of bi-4SCAR-CD19/79b T cells at 10\^6 cells/kg body weight via IV
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05436509