Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Utomilumab in Adults With Refractory Large B-cell Lymphoma — ZUMA-11  

Relapsed/Refractory Large B-cell Lymphoma Clinical Trial

Official title: A Phase 1/2 Multi-center Study Evaluating the Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Utomilumab in Subjects With Relapsed/Refractory Large B-Cell Lymphoma

Status Terminated

Clinical Trial Summary

The primary objectives of this study are:

Phase 1: To evaluate the safety of axicabtagene ciloleucel in combination with utomilumab and to identify the most appropriate dose and timing of utomilumab to carry forward into Phase 2

Phase 2: To evaluate the efficacy of axicabtagene ciloleucel and utomilumab in participants with refractory large B-cell lymphoma

Clinical Trial Description

This study was intended to be a Phase 1/2, but the planned Phase 2 part has been canceled.

After the study, participants who received an infusion of axicabtagene ciloleucel and utomilumab will complete the remainder of the 15-year follow-up assessments in a separate Long-term Follow-up study, KT-US-982-5968. ;

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Relapsed/Refractory Large B-cell Lymphoma

• NCT number: NCT03704298
• Study type: Interventional
• Source: Gilead Sciences
• Status: Terminated
• Phase: Phase 1
• Start date: November 20, 2018
• Completion date: December 15, 2022