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

NCT04314843 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-03-04

Study results available
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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.

Conditions

  • Relapsed/Refractory Large B-cell Lymphoma

Interventions

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.

Sponsors & Collaborators

  • Humanigen, Inc.

    collaborator INDUSTRY

  • Kite, A Gilead Company

    lead INDUSTRY

Principal Investigators

  • Kite Study Director · Kite, A Gilead Company

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-26
Primary Completion
2021-03-16
Completion
2022-07-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04314843 on ClinicalTrials.gov