CAR-T Cell Therapy Targeting to CD19 for R/R ALL
CD19-targeting Chimeric Antigen Receptor T-cell Therapy for Patients With Refractory and Relapsed B-cell Acute Lymphoblastic Leukemia
PhasePhase 1/Phase 2
Lead SponsorSoochow University
Indication/ConditionAcute Lymphoblastic Leukemia With Failed Remission
Intervention/TreatmentCAR T-cell therapy
Refractory and relapsed (R/R) acute lymphoblastic leukemia (ALL) patients with active disease always have a dismal outcome. Chimeric antigen receptor (CAR) T-cell therapy targeting to Cluster of Differentiation Antigen 19 (CD19) has been proved as a potent approach to attain remission in B-cell R/R patients. Therefore, the investigators conduct a trial to evaluate the the efficacy and safety of locally producing CAR T cells targeting CD19, and to analyze the outcome of enrolled B-cell ALL patients with active disease or persistent residual disease.
Patients enrolled will receive infusion of CD19-targeting CAR T-cells with a target dose of 5~10×10E6/kg of recipient weight, after the preparative regimen consisted of fludarabin (30mg/m2, day -5 to -3) and cyclophosphamide (300mg/m2, day -5 to -3).
Patients enrolled will receive infusion of CD19-targeting CAR T-cells
Inclusion Criteria: Diagnosed as CD19+ B-cell acute lymphoblastic leukemia; Fail to achieve remission, or with persistent residual disease after at least 2 cycles of consolidation; With an estimated survival of higher than 3 months (according to investigator's judgement); Sufficient organ function: left ventricular ejection fractions≥ 0.5 by echocardiography, creatinine < 1.6 mg/dL, aspartate aminotransferase/aspartate aminotransferase < 3 x upper limit of normal, bilirubin <2.0 mg/dL; Karnofsky performance status ≥ 60 or ECOG ≤ 2. Exclusion Criteria: Intolerant to immunosuppressive chemotherapies; With active infection or other uncontrolled complications; With history of seizure; Active hepatitis B or hepatitis C infection and HIV infection; Pregnant or lactating women, or patients refusing to take effective contraception measures; Other contraindications that considered inappropriate to participate in this trial (according to investigator's judgement).