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Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3)

NCT04880434 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2025-11-17

No results posted yet for this study

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

DRUG

Fludarabine

Administered intravenously

DRUG

Cyclophosphamide

Administered intravenously

BIOLOGICAL

Brexucabtagene autoleucel

A single infusion of brexucabtagene autoleucel (KTE-X19) 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
2021-04-27
Primary Completion
2025-06-17
Completion
2025-06-17
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Netherlands
  • Spain
  • United Kingdom

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 NCT04880434 on ClinicalTrials.gov