4SCAR19U T Cells Targeting B Cell Malignancies
Universal 4SCAR19U T Cell Therapy for the Treatment of Relapsed and Refractory B Cell Malignancies
Shenzhen Geno-Immune Medical Institute
30 participants
Oct 31, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- Age older than 6 months.
- Primary B cell surface expression of CD19.
- 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 response after treatment.
- 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 CAR-T treatment.
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Interventions
Infusion of 4SCAR19U cells
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05995015