CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia (1922CAR)
Summary
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.
Detailed description
Treatment will include a single course of lymphodepleting chemotherapy (fludarabine/cyclophosphamide) followed by CAR T cell infusion. CAR T cell dose will be determined by the protocol-defined dose escalation scheme, based on the number of CAR+ T cells and participant weight.
Arms & interventions
- DrugFludarabine
IV
- DrugCyclophosphamide
IV
- DrugMesna
IV
- DeviceCD19-CD22 CAR T cell infusion
CAR T cell infusion will be given intravenously, either centrally or peripherally.
Outcome measures
Primary
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).
Time frame: up to 4 weeks after CD19-CD22-CAR T-cell infusion
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.
Time frame: up to 4 weeks after CD19-CD22-CAR T-cell infusion
Eligibility criteria
Study locations (1)
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105