Clinical Trial

Orphan Indications for CD19 Redirected Autologous T Cells

Recruiting Phase 2
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Summary
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).
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2020-02-17; most recent amendment 2026-03-04.
Status change: Active, Not Recruiting → Recruiting 2023-01-25
Status change: Recruiting → Active, Not Recruiting 2021-06-07
Status change: Not Yet Recruiting → Recruiting 2020-03-16
Trial Details
NCT Number NCT04276870
Lead Sponsor Stephan Grupp MD PhD
Collaborators: University of Pennsylvania
Conditions Pediatric and Young Adult Patientswith Hypodiploid or t(17;19) B-ALL, Infants With Very High Risk KMT2A B-ALL, Patients With Central Nervous System Relapse Who Did Not Receive Cranial Radiation or Bone Marrow Transplantation
Enrollment 133 participants
Start Date 2020-03-12
Primary Completion 2028-03-10 (estimated)
Study Completion 2037-03-10 (estimated)
Updated on ClinicalTrials.gov 2026-03-06