A Phase 1/2, Open-label, Single Arm, Multicohort, Multicenter Trial to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects With Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL).

Study Summary

This is a Phase 1/2, open-label, single arm, multicohort study to evaluate the safety and efficacy of JCAR017 in pediatric subjects aged ≤ 25 years with CD19+ r/r B-ALL and B-NHL. Phase 1 will identify a recommended Phase 2 dose (RP2D). Phase 2 will evaluate the efficacy of JCAR017 RP2D in the following three disease cohorts: Cohort 1 (r/r B-ALL), Cohort 2 (MRD+ B-ALL) and Cohort 3 (r/r B-NHL, \[DLBCL, BL, or PMBCL\]). A Simon's Optimal two-stage study design will be applied to Cohort 1 and 2 in Phase 2.

Interventions

Study Locations

Facility	City	State	Country
Local Institution - 163	Duarte	California	United States
Local Institution - 167	Redwood City	California	United States
Local Institution - 166	St. Petersburg	Florida	United States
Local Institution - 160	New York	New York	United States
Local Institution - 162	Philadelphia	Pennsylvania	United States
Local Institution - 164	Dallas	Texas	United States
Local Institution - 165	Houston	Texas	United States
Local Institution - 161	Seattle	Washington	United States
Local Institution - 168	Wauwatosa	Wisconsin	United States
Local Institution - 601	Lyon		France
Local Institution - 602	Marseille		France
Local Institution - 600	Paris		France
Local Institution - 501	Berlin		Germany
Local Institution - 500	Frankfurt		Germany
Local Institution - 301	Monza		Italy
Local Institution - 300	Roma		Italy
Local Institution - 400	Utrecht		Netherlands
Local Institution - 251	Esplugues de Llobregat		Spain
Local Institution - 250	Madrid		Spain

Official Trial Information

View on ClinicalTrials.gov