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

NCT03704298 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-06-28

Study results available
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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

Conditions

  • Relapsed/Refractory Large B-cell Lymphoma

Interventions

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

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Kite, A Gilead Company

    lead INDUSTRY

Principal Investigators

  • Kite Study Director · Kite, A Gilead Company

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-20
Primary Completion
2021-05-07
Completion
2022-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT03704298 on ClinicalTrials.gov