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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
CD22CART will be administered after Standard of Care (SOC) administration of tisagenlecleucel.
All enrolled participants will receive lymphodepletion followed by standard of care tisagenlecleucel infusion.
Stanford University
Palo Alto, California, United States
RECRUITINGThe number of patients who experience dose limiting toxicities (Phase 1)
The number of patients who experience dose limiting toxicities within 28 days of administration of CD22 CART when given within 28-42 days of infusion of tisagenlecleucel
Time frame: 28 days after single infusion of CD22 CAR T cells
The number of patients who successfully receive infusion of CD22CART (Phase 1b)
The number of patients who successfully receive infusion of CD22CART within 42 days of infusion of tisagenlecleucel
Time frame: within 42 days of infusion of tisagenlecleucel
Number of patients who have no evidence of leukemia
Number of patients who have no evidence of leukemia (complete response or complete response with incomplete count recovery) at Day 28 following CD22 CART infusion.
Time frame: 28 days after single infusion of CD22 CAR T cells
The number of patients who have B cell aplasia
The number of patients who have B cell aplasia 6 months following tisagenlecleucel and CD22 CART infusion
Time frame: 6 months following single infusion of CD22 CAR T cells and tisagenlecleucel
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