This study is a phase I study designed to evaluate the safety of CD19-CD22-CAR T cells.
Primary Objective:
To determine the safety profile and propose the recommended phase 2 dose (RP2D) of autologous CD19-CD22-CAR T cells in patients ≤ 21 years of age with recurrent/refractory CD19- and/or CD22-positive leukemia.
Secondary Objective:
To evaluate the anti-leukemic activity of CD19-CD22-CAR T cells.
Age <21 years old
Second or greater relapse
Any relapse after allogeneic HCT
Refractory disease (primary or in relapse) despite therapy designed to induce remission
Known primary immunodeficiency
Known HIV positivity
Known contraindication to receiving protocol defined lymphodepleting
chemotherapy regimen
Single group
Fludarabine
DrugIV
Cyclophosphamide
DrugIV
Mesna
DrugIV
CD19-CD22 CAR T cell infusion
DeviceCAR T cell infusion will be given intravenously, either centrally or peripherally.
Recommended phase 2 dose (RP2D) of CD19-CD22-CAR T cells
Phase I design to determine the RP2D of CD19-CD22-CAR T cells. Two (2) dose levels will be evaluated (1x106 and 3x106cells/kg).
Incidence of adverse events
Will be assessed and graded using the CTCAE v5.0, with the exception of CRS and ICANS, which will be graded according to ASTCT Consensus Guidelines. Adverse events will be summarized descriptively and dose limiting toxicity (DLT) rate will be reported.
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