Leukemia Clinical Trial
Official title:
Phase I/Ib Clinical Trial of Autologous CD22 Chimeric Antigen Receptor (CAR) T Cells Following Commercial CD19 CAR T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies
The primary purpose of this study is to determine safety, feasibility, and the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of CD22 Chimeric Antigen Receptor T-Cell Therapy (CART) cells when administered 28 to 42 days after an infusion of a commercial CAR called Tisagenlecleucel, to children and young adults with relapsed or refractory B-cell leukemia.
Primary Objectives: Phase 1 portion (Safety lead-in): Determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) dose of CD22CART in children and young adults with R/R CD19 and CD22 expressing B-cell malignancies administered after infusion of tisagenlecleucel according to FDA approved dose range. Phase 1b portion (Expansion cohort) Establish the feasibility of delivering CD22CART following infusion of commercial tisagenlecleucel, administered per FDA approved Package Insert, in children and young adults with B cell malignancies. Determine the safety of administering the RP2D of CD22CART 28 to 42 days after infusion of FDA approved commercial tisagenlecleucel in children and young adults with B cell malignancies. Secondary Objectives: 1. Describe the clinical activity of serial infusion of tisagenlecleucel followed by CD22CART in children and young adults with R/R B-cell malignancies. 2. Assess the rate of ongoing B cell aplasia at 6 months after initial tisagenlecleucel infusion, when tisagenlecleucel is followed by serial CD22CART infusion within 42 days. ;
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