NCT04314843

Study of Lenzilumab and Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma

A Phase 1/2 Open-label, Multicenter Study of Lenzilumab and Axicabtagene Ciloleucel in Subjects With Relapsed or Refractory Large B-cell Lymphoma (ZUMA-19)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (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 sequenced therapy with lenzilumab and axicabtagene ciloleucel in participants with relapsed or refractory large B-cell lymphoma and identify the most appropriate dose of lenzilumab for Phase 2. Phase 2: To evaluate the incidence of neurologic events with sequenced therapy given at the recommended Phase 2 dose (RP2D) of lenzilumab in participants with relapsed or refractory large B-cell lymphoma.

Detailed description

This study was intended to be a Phase 1/2, but the planned Phase 2 part has been canceled. All participants who received an infusion of lenzilumab and axicabtagene ciloleucel will be provided the opportunity to transition to a separate long-term follow-up (LTFU) study, KT-US-982-5968.

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	Lenzilumab	Administered as an IV infusion
BIOLOGICAL	Axicabtagene Ciloleucel	A single infusion of chimeric antigen receptor (CAR) transduced autologous T cells administered intravenously.

Timeline

• Start date: 2020-05-26
• Primary completion: 2021-03-16
• Completion: 2022-07-27
• First posted: 2020-03-19
• Last updated: 2024-03-04
• Results posted: 2024-03-04

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study