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COMPLETED Phase 2

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

NCT04880434 · View on ClinicalTrials.gov ↗

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).

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • BIOLOGICAL Brexucabtagene autoleucel

Study Locations (20)

Illinois

  • University of Chicago — Chicago
  • Loyola University Medical Center — Maywood
  • Advocate Aurora Health - Advocate Lutheran General Hospital — Park Ridge

California

  • Stanford University — Palo Alto
  • University California Los Angeles (UCLA) — Santa Monica

Florida

  • University of Miami — Miami
  • Moffitt Cancer Center — Tampa

Ohio

  • Cleveland Clinic - Taussig Cancer Institute — Cleveland
  • Ohio State University — Columbus

Tennessee

  • Sarah Cannon - Tenessee — Nashville
  • Vanderbilt University — Nashville

Arizona

  • Banner MD Anderson Cancer Center — Gilbert

Colorado

  • Sarah Cannon- Denver — Denver

Georgia

  • Emory University — Atlanta

Trial Details

FieldValue
Enrollment Target 95 participants
Start Date 2021-04-27
Est. Completion 2025-06-17
Phase Phase 2

Sponsor

Kite, A Gilead Company

11 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04880434

The ClinicalTrials.gov registry entry for NCT04880434 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kite, A Gilead Company, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Relapsed/Refractory Mantle Cell Lymphoma appearing as the primary indexed condition, and to 3 interventions — of which Cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04880434 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Illinois, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04880434 about?

NCT04880434 is a clinical study titled "Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3)". 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).

What is the current status of trial NCT04880434?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2021-04-27. Estimated completion is 2025-06-17.

What conditions does trial NCT04880434 study?

This clinical trial studies the following conditions: Relapsed/Refractory Mantle Cell Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04880434?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Brexucabtagene autoleucel (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04880434?

This trial is sponsored by Kite, A Gilead Company, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04880434 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial