Study Evaluating KTE-C19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

Official Title

A Phase 1/2 Multi-Centre Study Evaluating the Safety and Efficacy of KTE-C19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-4)

Summary:

The primary objectives of this study are to evaluate the safety and efficacy of KTE-C19 in pediatric and adolescent participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL).

Trial Description

Primary Outcome:

• Phase 1: Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities (DLT)
• Phase 2: Overall Complete Remission Rate

• Duration of Remission
• Minimum Residual Disease Negative Remission Rate
• Allogeneic Stem Cell Transplant Rate
• Overall Survival
• Relapse-Free Survival
• Percentage of Participants Experiencing Treatment-Emergent Adverse Events
• Percentage of Participants Experiencing Common Terminology Criteria for Adverse Events (CTCAE) Grade Changes in Safety Laboratory Values
• Percentage of Participants with Anti-KTE-C19 Antibodies

View this trial on ClinicalTrials.gov