Last updated on May 2018

Safety and Efficacy Evaluation of IM19 CAR-T Cells

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: leukemia
  • Age: Between 4 - 65 Years
  • Gender: Male or Female

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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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