This is an open-label, four-cohort, phase 2 study to determine the efficacy of CART19 in pediatric and young adult patientswith hypodiploid (Cohort A) or t(17;19) B-ALL (Cohort B), infants with very high risk KMT2A B-ALL (Cohort C), and in patients with central nervous system (CNS) relapse who did not receive cranial radiation (XRT) or bone marrow transplantation (BMT) (Cohort D).
Signed informed consent form must be obtained prior to any study procedure.
Male and female patients with documented CD19+ B-ALL
Documentation of CD19 tumor expression in bone marrow, peripheral blood, CSF, or tumor tissue.
Age 0 to 29 years
For subjects with a CNS relapse, prior cranial XRT or BMT for the current relapse is an exclusion.
Active hepatitis B or active hepatitis C.
HIV Infection.
Active acute or chronic graft-versus-host disease (GVHD) requiring systemic therapy.
Stephan Grupp MD PhD
Lead sponsor
Children's Hospital of Philadelphia
Sponsor institution
University of Pennsylvania
Collaborator