Overview
This is a single center,randomized ,two-cohorts, open-label ,phase 1/2 study to evaluate the efficacy and safety of T cells expressing humanized CD19 chimeric antigen receptors treatment for relapsed/refractory CD19+ acute lymphoblastic leukemia patients.
Description
Relapsed/refractory CD19 + acute lymphoblastic leukemia patients were randomly enrolled in this study to compare the efficacy and safety between two cohorts: 1. Humanized CD19 CAR-T cells； 2. Humanized CD19 CAR-T cells with CRS suppression technology.
Eligibility
Inclusion Criteria:
- Age 6 to 65
- Voluntary informed consent is given
- Expected survival ≥12 weeks
- Relapsed or refractory CD19+ acute leukemia, ineligible for allo-HSCT,or relapse after auto-HSCT
- Organ function: (1)Left ventricular ejection fractions≥ 0.6 by echocardiography (2)ALT ≤3 times of ULN, or bilirubin <2.0 mg/dl (3)Creatinine < 2 mg/dl and less than 2.5 × normal for age (4)Prothrombin time and activated partial thromboplastin time < 2 times of ULN (5)Arterial oxygen saturation> 92%
- Karnofsky score ≥ 60 ;
- No history of combined chemotherapy in the recent 1 month and no immunotherapy in the recent 3 months;
Exclusion Criteria:
- Uncontrolled active infections
- Active hepatitis B or hepatitis C infection
- HIV infection
- History of myocardio infarction in the past 6 months, or history of severe arrhythmia
- Congenital immunodeficiency
- Pregnant or lactating women
- History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
- Previous treatment with any gene therapy products