NCT03704298

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Kite, A Gilead Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 as measured by complete response rate in participants with refractory large B-cell lymphoma

Detailed description

This study was intended to be a Phase 1/2. Enrollment was stopped prior to completion of Phase 1 portion of the study based on the sponsor's decision to end the program. No participants were enrolled in Phase 1 Cohort 5 and Phase 2. After the study ends, 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 (NCT05041309).

Conditions

• Relapsed/Refractory Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Administered according to package insert
DRUG	Fludarabine	Administered according to package insert
BIOLOGICAL	Axicabtagene Ciloleucel	A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously
BIOLOGICAL	Utomilumab	Administered as an IV infusion

Timeline

• Start date: 2018-11-20
• Primary completion: 2021-05-07
• Completion: 2022-12-15
• First posted: 2018-10-12
• Last updated: 2024-06-28
• Results posted: 2024-06-28

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study