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
Stanford University
Summary
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.
Description
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 th…
Eligibility
- Age range
- 1–25 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Diagnosis of histologically confirmed relapsed/refractory (R/R) B cell acute lymphoblastic leukemia (ALL) 2. Must be eligible to receive commercial KYMRIAH® (tisagenlecleucel) according to FDA approved package insert (refractory disease or in second or later relapse) 3. CD19 and CD22 expression must be demonstrated on malignant cells by immunohistochemistry or flow cytometry. CD19 and CD22 expression at any level of expression will be acceptable, as that is the standard for commercial KYMRIAH® (tisagenlecleucel) and the optimal level of CD22 expression is not well defin…
Interventions
- DrugCD22CART infusion
CD22CART will be administered after Standard of Care (SOC) administration of tisagenlecleucel.
- DrugTisagenlecleucel
All enrolled participants will receive lymphodepletion followed by standard of care tisagenlecleucel infusion.
Location
- Stanford UniversityPalo Alto, California