This study will evaluate the safety and tolerability of administering a novel bispecific CD19/CD22-directed CAR T cell product (CD19x22) for the treatment of relapsed or refractory pediatric B-ALL.
Relapsed two or more times.
Relapsed at any time after allogeneic bone marrow transplant (BMT).
Relapse or refractory after single antigen targeting CAR T cell therapy.
CD19 and/or CD22 present on last relapsed/refractory disease evaluation.
Active, uncontrolled central nervous system (CNS) leukemia that is progressive despite other therapies or leading to CNS symptoms (including but not limited to: seizures, paresis, aphasia, hemorrhage, dementia, psychosis, or movement disorders) as determined by the treating physician at eligibility, prior to lymphodepleting chemotherapy (LD chemo), and pre- CD19x22 CAR T cell infusion.
Less than 100 days post-transplant;
Evidence of active Graft-versus-Host Disease (GvHD) requiring systemic therapy;
Less than 6 weeks post donor lymphocyte infusion (DLI).
Parallel
CD19x22 CAR T
Biological/VaccineThe investigational product is an autologous, genetically modified CD19xCD22 CAR T cell product produced by the Gates Biomanufacturing Facility.
Safety Measured by Dose Limiting Toxicities (DLTs)
The safety of the administering this bispecific CD19/CD22-directed CAR T cell product will be measured by assessing the DLTs in each disease burden cohort in a Bayesian optimal interval (BOIN) design to determine the MTD
Overall Response Rate
The efficacy of this bispecific CD19/CD22-directed CAR T cell product will be measured by evaluating the overall response rate in each disease burden stratum based on a morphologic disease assessment to measure bone marrow status at Day 28 post-infusion.
Minimal Residual Disease (MRD) Rate
The efficacy of this bispecific CD19/CD22-directed CAR T cell product will be monitored in each disease burden stratum by measuring peripheral blood MRD by next generation sequencing
Minimal Residual Disease (MRD) Rate
The efficacy of this bispecific CD19/CD22-directed CAR T cell product will be monitored in each disease burden stratum by measuring bone marrow MRD by flow cytometry and/or next generation sequencing.
CD19-Relapse
Cumulative incidence of CD19-relapse as determined by immunophenotype of leukemic blasts for subjects in each disease burden stratum will be calcualted using standard techniques using all enrolled patients and compared to published literature both from pre- and post-licensing clinical trials and/or reports.
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