CAR-T Cell Therapy Targeting to CD19 for R/R ALL

Condition(s) studied

Investigational drug(s) / intervention(s)

CAR 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.

Study 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

Primary outcome measure(s)

• Completeremission — 1 month post infusion
  defined as less than 5% blasts in the bone marrow without myelosuppression, no circulating blasts in peripheral blood, and the absence of extramedullary disease, regardless of cell count recovery
• Minimal residual disease response — 1 month post infusion
  defined as less than 0.01% bone marrow blasts assessed by multiparameter flow cytometry, and absence of genetic aberrants assessed by karyotype analysis or molecular detection
• Leukemia-free survival — 3 year post infusion
  calculating from the day of CAR T-cell infusion to death, disease progression or the end of follow-up

Trial sites (1)

More The First Affiliated Hospital of Soochow University trials in China

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