Safety and Efficacy Evaluation of IM19 CAR-T Cells

Exclusion Criteria

• •To be aged 4 to 65 years
• •Estimated survival of ≥ 6 months, but ≤ 2 years
• •ECOG score ≤2
• •Relapse after auto-HSCT
• •Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time.
• •Voluntary participation in the clinical trials and sign the informed consent.
• •History of epilepsy or other CNS disease
• •Patients have GVHD, which needs treatment with immunosuppressive agents
• •Patients with prolonged QT interval or severe heart disease
• •Patients in pregnancy or breast-feeding period
• •Uncontrolled active infection
• •Active hepatitis B or hepatitis C infection
• •Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
• •Previously treatment with any gene therapy products
• •Feasibility assessment during screening demonstrates \<30% transduction of target lymphocytes, or insufficient expansion (\<5-fold) in response to CD3/CD28 costimulation
• •ALT /AST\>3 x normal value; Creatinine\> 2.5 mg/dl; Bilirubin \>2.0 mg/dl
• •HIV infection
• •Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.