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Outpatient CAR T-Cell therapy shows promise for tough lymphoma

NCT ID NCT05459571

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested a cancer treatment called axicabtagene ciloleucel (a CAR T-cell therapy) given with preventive steroids to 35 adults with large B-cell lymphoma that had returned or not responded to prior treatments. The goal was to see if giving the therapy in an outpatient setting (without staying overnight in the hospital) is safe and manageable. Researchers tracked side effects like cytokine release syndrome and nerve problems, as well as how many people needed hospitalization.

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

35 people

The number who actually took part.

Started

Aug 2022

Finished

Nov 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: * Histologically confirmed large B-cell lymphoma (LBCL), including the following types defined by World Health Organization (WHO) 2016 classification, by local pathology laboratory assessment, are eligible as defined below: * Diffuse large B-cell lymphoma (DLBCL) not otherwise specified. * High-grade B-cell lymphoma (HGBL) with or without MYC and BCL2 and/or BCL6 rearrangement. * DLBCL associated with chronic inflammation; Epstein-Barr virus (EBV) + DLBCL. * Primary mediastinal (thymic) LBCL. * Primary cutaneous DLBCL, leg type. * Transformation of follicular lymphoma to DLBCL will also be included. * Relapsed or refractory disease after 1 or more lines of therapy. * Individuals must have received adequate prior therapy including: * Anti-CD20 monoclonal antibody AND * An anthracycline-containing chemotherapy regimen. * At least 1 measurable lesion according to the Lugano Response Criteria for Malignant Lymphoma. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Individual agrees to outpatient treatment setting and to adhere to the prespecified clinical monitoring requirements. Key Exclusion Criteria: * History of autologous or allogeneic stem cell transplant. * Prior cluster of differentiation (CD)19 targeted therapy. * Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy. * Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management. Simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the Kite medical monitor. * Individuals with detectable cerebrospinal fluid malignant cells, brain metastases, or with a history of central nervous system (CNS) lymphoma or primary CNS lymphoma. DLBCL epidural involvement should be considered as positive CNS disease. * In the investigator's judgment, the individual is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

Recurrence relapsed/refractory diffuse large B-cell lymphoma

As listed by the trial registrant

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

Relapsed or refractory large B-cell lymphoma

Contacts and locations

Locations

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

    Duarte, California, 91010, United States

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • Henry-Joyce Cancer Clinic

    Nashville, Tennessee, 37232, United States

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah, 84112, United States

  • Intermountain Healthcare

    Murray, Utah, 84107, United States

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Methodist Healthcare System of San Antonio

    San Antonio, Texas, 78229, United States

  • Oncology Hematology Care Clinical Trials, LLC

    Cincinnati, Ohio, 45242, United States

  • Prisma Health - Upstate

    Greenville, South Carolina, 29615, United States

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203, United States

  • UCLA

    Los Angeles, California, 90025, United States

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22908, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23219, United States

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502, United States

More trials for these conditions

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