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.
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.
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.
Single group
Therapeutic 4SCAR19 cells
GeneticAutologous 4th generation withdrawal lentiviral-transduced 4S CAR-T19
Safety of fourth generation anti CD19 CAR-T cells in patients with relapsed B cell malignancies using CTCAE 4 standard to evaluate the level of adverse events
physiological parameter (for safety, measuring cytokine response, fever, symptoms)
Anti tumor activity of fourth generation anti CD19 CAR-T cells in patients with relapsed or refractory B cell malignancies
scale of CAR copies and leukemic cell burden (for efficacy)
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