Safety and Efficacy Evaluation of IM19 CAR-T Cells

Safety and Efficacy Evaluation of IM19 CAR-T Cells on Refractory or Relapsed B-ALL Patients

Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia or CD19+ B-all.

Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia or CD19+ B-ALL patients and determine the MTD,LTD and the best dosage.

Inclusion Criteria:

• Patients with CD19+ leukemia, meeting the following criteria

  • At least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody (Rituximab) therapy)
  • Less than 1 year between last chemotherapy and progression
  • Not eligible or appropriate for allo-HSCT

• 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.

Exclusion Criteria:

• 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
• Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial
• HIV infection
• Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.