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Engineered immune cells show promise against tough lymphoma

NCT ID NCT04880434

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Updated 2 times

Summary

This phase 2 study tested a personalized cell therapy called KTE-X19 (brexucabtagene autoleucel) in 95 adults with mantle cell lymphoma that had returned or stopped responding to prior treatments. Participants received a single infusion of their own genetically modified immune cells designed to attack the cancer. The main goal was to see how many patients had their tumors shrink or disappear.

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), a CAR T-cell therapy made from the patient's own immune cells
What this could lead to
If successful, this could provide a powerful treatment option for people with mantle cell lymphoma that has stopped responding to other therapies.
What could go wrong
This is a phase 2 trial with 95 participants, so results are not yet confirmed in larger groups. CAR T-cell therapy can cause serious side effects like cytokine release syndrome and neurological problems.

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

95 people

The number who actually took part.

Started

Apr 2021

Finished

Jun 2025

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 (MCL). Prior therapy must have included anthracycline- or bendamustine-containing chemotherapy and anti-cluster of differentiation 20 (CD20) monoclonal antibody therapy. Individuals must not have received prior therapy with a Bruton's tyrosine kinase inhibitor (BTKi). * At least 1 measurable lesion * Platelet count ≥ 75,000/μL * Creatinine clearance (as estimated by Cockcroft Gault) ≥ to 60 cc/min * Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA), 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 anti-hepatitis C virus (HCV) positive. Individuals with a history of hepatitis infection must have cleared their infection as determined by 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, 1100, Netherlands

  • Advocate Aurora Health - Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068, United States

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Baylor Cancer Hospital

    Dallas, Texas, 75246, United States

  • CHU de Montpellier

    Montpellier, 34295, France

  • CHU de Rennes

    Rennes, 35033, France

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495, France

  • Cleveland Clinic - Taussig Cancer Institute

    Cleveland, Ohio, 44195, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Erasmus MC

    Rotterdam, 3015 CE, Netherlands

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Hopital Haut-Leveque

    Pessac, 44035, France

  • Hospital Clinic Barcelona

    Barcelona, Spain

  • Hospital Saint Louis

    Paris, 75010, France

  • Hospital Universitari Vall D'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario de Salamanca

    Salamanca, 37007, Spain

  • Johannes Gutenberg University Hospital-University Mainz

    Mainz, 55101, Germany

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Kings College Hospital

    London, SE5 9RS, United Kingdom

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Manchester Royal Infirmary

    Manchester, M13 9WL, United Kingdom

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Munich University of Technology-Medical Faculty- Ethics Committee

    München, 81377, Germany

  • Ohio State University

    Columbus, Ohio, 43220, United States

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF, United Kingdom

  • Sarah Cannon - Tenessee

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon- Denver

    Denver, Colorado, 80218, United States

  • Stanford University

    Palo Alto, 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, 9700 RB, Netherlands

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • Vanderbilt University

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.