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
  • Phase

    Phase 1/Phase 2
  • Study Type

  • Status

  • Study Participants

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.
Study Started
Dec 01
Primary Completion
Dec 31
Study Completion
Dec 31
Last Update
Jul 01

Biological CAR T-cell therapy

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).

CAR T-cell therapy Experimental

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).
No Results Posted