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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6+
SponsorShenzhen Geno-Immune Medical Institute

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Therapeutic 4SCAR19 cells

Treatment groups

200 Participants
are divided into 1 treatment group