NCT03792633

Study of huCART19 for Very High-Risk (VHR) Subsets of Pediatric B-ALL

Phase 2 Study of Humanized CD19-directed Chimeric Antigen Receptor-modified T Cells (huCART19) for Very High-Risk Subsets of B Cell Acute Lymphoblastic Leukemia (B-ALL)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 3 Months – 29 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2 study to evaluate humanized CD19 redirected autologous T cells (or huCART19 cells) with CD19 expressing relapsed and refractory B-cell acute lymphoblastic leukemia. This study is targeting pediatric and young adult patients aged 3 months - 29 years with CD19+ B cell malignancies in newly diagnosed B-ALL patients predicted to have an exceedingly poor outcome with conventional chemotherapy, in high-risk first relapse, or and in second or greater relapse in this phase 2 trial. In addition, a second cohort will test the efficacy of huCART19 in patients with poor response to prior B cell directed engineered cell therapy.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	huCART19	IV injection

Timeline

• Start date: 2019-01-18
• Primary completion: 2024-04-04
• Completion: 2024-04-04
• First posted: 2019-01-03
• Last updated: 2025-06-05
• Results posted: 2025-05-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study