Title
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
Phase
Phase 1Study Type
InterventionalStatus
Unknown statusIndication/Condition
LeukemiaIntervention/Treatment
cd19 car-t cells ...Study Participants
60Assessment 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.
All patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD19 CAR will be infused 24-96 hours later.
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by a single infusion of IM19CART cells administered intravenously.
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.
