Study Evaluating Brexucabtagene Autoleucel (KTE-X19) in Pediatric and Adolescent Participants With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma

Official Title

A Phase 1/2 Multi-Centre Study Evaluating the Safety and Efficacy of KTE-X19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (ZUMA-4)

Summary:

The primary objectives of this study are to evaluate the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in pediatric and adolescent participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL) or relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (NHL).

Trial Description

Primary Outcome:

• Phase 1: Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities (DLT)
• Phase 2: Overall Complete Remission Rate in the ALL Cohort
• Phase 2: Objective Response Rate in the NHL Cohorts

• Minimum Residual Disease Negative Remission Rate in the ALL Cohort
• Allogeneic Stem Cell Transplant Rate in the ALL Cohort
• Changes Over Time in Patient Reported Outcomes (PRO) Scores in the ALL and NHL Cohorts
• Overall Complete Remission Rate in the ALL Cohort
• Relapse-Free Survival for the ALL Cohort
• Progression Free Survival in the NHL Cohort
• Overall Survival in the ALL and NHL Cohorts
• Duration of Remission in the ALL and NHL Cohorts
• Percentage of Participants with Anti-Brexucabtagene Autoleucel (KTE-X19) Antibodies in Blood in the ALL and NHL Cohorts
• Percentage of Participants Experiencing Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) Grade Changes in Safety Laboratory Values in ALL and NHL Cohorts

View this trial on ClinicalTrials.gov