A Study 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)

Complete Title: SC-2032 A PHASE 1B/2, OPEN-LABEL, SINGLE ARM, MULTICOHORT, MULTICENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF JCAR017 IN PEDIATRIC SUBJECTS WITH RELAPSED/REFRACTORY B-ALL AND B-NHL
Trial Phase: I/II
Investigator: Rebecca Gardner

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.

Keywords:
  • Lymphoma, Non-Hodgkin (NHL)
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
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Adult
Pediatric
I/II
Rebecca Gardner
RG1004546
NCT03743246
SC-2032 A PHASE 1B/2, OPEN-LABEL, SINGLE ARM, MULTICOHORT, MULTICENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF JCAR017 IN PEDIATRIC SUBJECTS WITH RELAPSED/REFRACTORY B-ALL AND B-NHL
Lymphoma, Non-Hodgkin (NHL)
Precursor Cell Lymphoblastic Leukemia-Lymphoma