NCT04276870

Orphan Indications for CD19 Redirected Autologous T Cells

CD19-Directed Chimeric Antigen Receptor CD19 Redirected Autologous T Cells (CART19) for Orphan Indications of Pediatric B Cell Acute Lymphoblastic Leukemia (B ALL)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 133 (estimated)
• Sponsor: Stephan Grupp MD PhD · Academic / Other
• Sex: All
• Age: 0 Years – 29 Years
• Healthy volunteers: Not accepted

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).

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

Interventions

Type	Name	Description
BIOLOGICAL	Murine CART19	CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv:41-BB:TCRζ, administered by IV injection with a planned dose of 5x106 CART19 cells/kg on day 0 with possible reinfusion/retreatment

Timeline

• Start date: 2020-03-12
• Primary completion: 2028-03-10
• Completion: 2037-03-10
• First posted: 2020-02-19
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study