RecruitingPhase 1Phase 2NCT03919240

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

Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

196 participants

Start Date

Dec 1, 2015

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoblastic Leukemia With Failed Remission

Summary

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 atrial 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.

Eligibility

Inclusion Criteria5

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/aspartateaminotransferase < 3 x upper limit of normal, bilirubin <2.0 mg/dL;
Karnofsky performance status ≥ 60 or ECOG ≤ 2.

Exclusion Criteria6

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).

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Interventions

BIOLOGICALCAR T-cell therapy

All enrolled patients will initially enter Arm A and receive CD19-targeted CAR T-cell therapy at a target dose of 5\~10×10E6 cells/kg after a lymphodepleting regimen consisting of fludarabine (30 mg/m²/day, days -5 to -3) and cyclophosphamide (300 mg/m²/day, days -5 to -3). Patients with an available eligible donor who consent to randomization will enter the RCT component and be randomized in a 2:1 ratio to Arm B1 (CAR T-cell therapy alone) or Arm B2 (CAR T-cell therapy followed by allo-HCT); all other patients will remain in Arm A.