RecruitingPhase 1Phase 2NCT03050190

A Phase I/II Multiple Center Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Malignancies

Sponsor

Shenzhen Geno-Immune Medical Institute

Enrollment

200 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

B-cell Malignancies

Summary

The study will evaluate safety and efficacy of a 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 (4SCAR19) for patients with B cell malignancies. Clinical response and development of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.

Eligibility

Min Age: 6 Months

Inclusion Criteria5

aged more than 6 months.
malignant B cell surface expression CD19 molecules.
the KPS score over 80 points, and survival time is more than 3 months.
greater Hgb 80 g/L.
no contraindications to solid and cell separation

Exclusion Criteria7

accompanied with other active diseases, the treatment is difficult to correct.
bacteria, fungus, or virus infection, unable to control.
people living with HIV.
active HBV and HCV infection.
of pregnancy and nursing mothers.
before entering the test of the use of glucocorticoid systemic treatment within a week.
confirmed before used CAR - but invalid