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Engineered immune cells show promise against tough lymphoma

NCT ID NCT02601313

Disease control Sponsor: Kite, A Gilead Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 study tested a single infusion of brexucabtagene autoleucel (KTE-X19), a CAR T-cell therapy, in 105 patients with relapsed or refractory mantle cell lymphoma. The treatment aims to help the body's own immune cells recognize and attack cancer. Results showed that many patients achieved a response, offering hope for those who have run out of standard options.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
brexucabtagene autoleucel (KTE-X19) CAR T cells
What this could lead to
If successful, this could provide a powerful treatment option for patients with hard-to-treat mantle cell lymphoma, potentially leading to long-term remission.
What could go wrong
This is a phase 2 trial with a relatively small number of participants. CAR T-cell therapy can cause serious side effects like cytokine release syndrome and neurological problems. Not all patients responded, and long-term durability is still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

105 people

The number who actually took part.

Started

Nov 2015

Finished

Sep 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: Up to 5 prior regimens for Mantle cell lymphoma. Prior therapy must have included: * Anthracycline or bendamustine-containing chemotherapy and * Anti-CD20 monoclonal antibody therapy and * Ibrutinib or acalabrutinib At least 1 measurable lesion Platelet count ≥ 75,000/uL Creatinine clearance (as estimated by Cockcroft Gault) \> or = to 60 mL/min Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings Baseline oxygen saturation \>92% on room air. Key Exclusion Criteria: * Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per standard serological and genetic testing * History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with central nervous system (CNS) involvement * Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

mantle cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsed/refractory mantle cell lymphoma

Contacts and locations

Locations

  • Academisch Medisch Centrum

    Amsterdam, Netherlands

  • Banner MD Anderson

    Gilbert, Arizona, 85234, United States

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246, United States

  • Centre Hospitalier Universitaire (CHU)

    Bordeaux, France

  • City of Hope

    Duarte, California, 91010, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Erasmus Medical Center

    Rotterdam, Netherlands

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • H Lee Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Hopital Haut-Leveque

    Pessac, 44035, France

  • Hospital Saint Louis

    Paris, 75010, France

  • Loyola University Chicago

    Maywood, Illinois, 60153, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Robert W. Franz Cancer Research Center

    Portland, Oregon, 97213, United States

  • Sarah Cannon

    Denver, Colorado, 80218, United States

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Stanford University

    Stanford, California, 94305, United States

  • Swedish Cancer Institute

    Seattle, Washington, 98104, United States

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97080, Germany

  • University California Los Angeles (UCLA)

    Santa Monica, California, 90404, United States

  • University Medical Center Groningen

    Groningen, Netherlands

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Universitätsklinik Dresden

    Dresden, 01307, Germany

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322, United States

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