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).