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Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2)

NCT02601313 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2026-03-18

Study results available
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Summary

The goal of this clinical study is to test how well the study drug, brexucabtagene autoleucel (KTE-X19), works in participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL).

Conditions

  • Relapsed/Refractory Mantle Cell Lymphoma

Interventions

BIOLOGICAL

brexucabtagene autoleucel

A single infusion of brexucabtagene autoleucel (KTE-X19) anti-CD 19 CAR T cells

DRUG

Cyclophosphamide

Administered intravenously

DRUG

Fludarabine

Administered intravenously

DRUG

Axicabtagene Ciloleucel

A single infusion of axicabtagene ciloleucel anti-CD 19 CAR T cells

Sponsors & Collaborators

  • 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
2015-11-09
Primary Completion
2023-09-22
Completion
2023-09-22
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Netherlands

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 NCT02601313 on ClinicalTrials.gov