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Relapsed or Refractory Large B-cell LymphomaPhase 2ZUMA-24NCT05459571

Study of Axicabtagene Ciloleucel Given With Steroids In Participants With Relapsed Or Refractory Large B-Cell Lymphoma

A Phase 2 study testing Axicabtagene Ciloleucel, Cyclophosphamide and Fludarabine in people with Relapsed or Refractory Large B-cell Lymphoma, run by Kite, A Gilead Company at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical study is to learn more about the study drug, axicabtagene ciloleucel, in participants with relapsed or refractory large B-cell lymphoma (LBCL) in the outpatient setting. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Axicabtagene Ciloleucel, Cyclophosphamide and Fludarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
16 sitesUnited States
Study dates
9 Aug 2022to 24 Nov 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 14Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Oncology Hematology Care Clinical Trials, LLC

    Cincinnati, Ohio, 45242

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

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

    Duarte, California, 91010

  • Prisma Health - Upstate

    Greenville, South Carolina, 29615

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • UCLA

    Los Angeles, California, 90025

  • Intermountain Healthcare

    Murray, Utah, 84107

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • Henry-Joyce Cancer Clinic

    Nashville, Tennessee, 37232

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Virginia Commonwealth University

    Richmond, Virginia, 23219

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah, 84112

  • Methodist Healthcare System of San Antonio

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase 2 Open-Label, Multicenter Study Evaluating The Safety And Efficacy of Axicabtagene Ciloleucel Concomitant With Prophylactic Steroids In Subjects With Relapsed Or Refractory Large B-Cell Lymphoma In The Outpatient Setting

The goal of this clinical study is to learn more about the study drug, axicabtagene ciloleucel, in participants with relapsed or refractory large B-cell lymphoma (LBCL) in the outpatient setting.

Read the detailed description

Participants who complete at minimum 24 months follow up will be transitioned to a separate long-term follow-up study (study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.

Being tested
Axicabtagene Ciloleucel, Cyclophosphamide, Fludarabine, Dexamethasone
Medical subject headings
Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Axicabtagene CiloleucelBiological

    Also called Yescarta®

    Administered intravenously

  • CyclophosphamideDrug

    Administered intravenously

  • FludarabineDrug

    Administered intravenously

  • DexamethasoneDrug

    Administered orally or intravenously

Study groups in NCT05459571
Study groupRoleWhat they receive
Axicabtagene CiloleucelExperimentalParticipant will receive lymphodepleting chemotherapy (cyclophosphamide 500 mg/m^2/day and fludarabine 30 mg/m^2/day) over 3 days (Days -5, -4, and -3) followed by prophylactic corticosteroid treatment with 10 mg dexamethasone on Day 0 (prior to axicabtagene ciloleucel), Day 1, and Day 2. Participant will receive axicabtagene ciloleucel consisting of a single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells on Day 0 (following dexamethasone 10 mg) at a target dose of 2 x 10^6 cells/kg.
Receives: Biological: Axicabtagene Ciloleucel; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage and Severity of Participants with Treatment-emergent Cytokine Release Syndrome (CRS) and Neurologic Events

    Measured: Up to 24 months

Secondary outcomes (25)

  1. Time to Onset of CRS and Neurologic Events Following Axicabtagene Ciloleucel Administration

    Measured: First infusion date of axicabtagene ciloleucel up to 24 months

  2. Duration of CRS and Neurologic Events Following Axicabtagene Ciloleucel Administration

    Measured: First infusion date of axicabtagene ciloleucel up to 24 months

  3. Rates of Hospitalization After Axicabtagene Ciloleucel Infusion as Measured by Proportion of Hospitalized Participants Within 72 hours

    Measured: First infusion date of axicabtagene ciloleucel up to 72 hours

  4. Rates of Hospitalization After Axicabtagene Ciloleucel Infusion as Measured by Proportion of Hospitalized Participants 3 Days After Infusion Date

    Measured: First infusion date of axicabtagene ciloleucel up to 3 days

  5. Rates of Hospitalization After Axicabtagene Ciloleucel Infusion as Measured by Proportion of Hospitalized Participants Within 7 days

    Measured: First infusion date of axicabtagene ciloleucel up to 7 days

  6. Rates of Hospitalization After Axicabtagene Ciloleucel Infusion as Measured by Proportion of Hospitalized Participants Within 14 days

    Measured: First infusion date of axicabtagene ciloleucel up to 14 days

  7. Rates of Hospitalization After Axicabtagene ciloleucel Infusion as Measured by Proportion of Hospitalized Participants Within 30 days

    Measured: First infusion date of axicabtagene ciloleucel up to 30 days

  8. Duration of Initial Hospitalization After Axicabtagene Ciloleucel Infusion

    Measured: First infusion date of axicabtagene ciloleucel up to 24 months

  9. Proportion of Intensive Care Unit (ICU) Admitted Participants

    Measured: Up to 24 months

  10. Duration of ICU Admission During First Hospitalization After Axicabtagene Ciloleucel Infusion

    Measured: Up to 24 months

  11. Percentage of Participants Experiencing Treatment- Emergent Adverse Events

    Measured: First infusion date of axicabtagene ciloleucel up to 24 months

  12. Percentage of Participants Experiencing Treatment- Emergent Serious Adverse Events

    Measured: First infusion date of axicabtagene ciloleucel up to 24 months

  13. Change in the European Quality of Life Five Dimensions Five Levels Scale (EQ-5D-5L) From Baseline to Month 6

    The EQ-5D-5 levels (EQ-5D-5L) is a standardized measure of health status of the participant that provides a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L consists of 2 components: a descriptive system of the participant's health and a rating of his or her current health state on a 0-100 VAS. The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Rating gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health.

    Measured: Baseline, 6 Months

  14. Objective Response Rate (ORR) as Assessed by Investigator Assessment

    ORR is defined as the incidence of either a complete response or a partial response by the revised international working group (IWG) response criteria for malignant lymphoma.

    Measured: Up to 24 months

  15. Complete Response (CR) Rate as Assessed by Investigator Assessment

    CR rate is defined as the incident of complete response.

    Measured: Up to 24 months

  16. Duration of response (DOR) as Assessed by Investigator Assessment

    DOR is defined as the time from first objective response to disease progression per the revised IWG response criteria for malignant lymphoma or death from any cause.

    Measured: Up to 24 months

  17. Progression-free Survival (PFS) as Assessed by Investigator Assessment

    PFS is defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per the revised IWG response criteria for malignant lymphoma or death from any cause.

    Measured: Up to 24 months

  18. Event Free Survival (EFS) as Assessed by Investigator Assessment

    EFS is defined as the time from infusion to the earliest date of disease progression per the revised IWG response criteria for malignant lymphoma, commencement of new anti-lymphoma therapy, or death from any cause.

    Measured: Up to 24 months

  19. Overall Survival (OS)

    OS is defined as the time from axicabtagene ciloleucel infusion to the date of death.

    Measured: Up to 24 months

  20. Peak Serum Levels of Homeostatic/Proliferative Cytokines: Interleukin (IL)-2, IL-7, and IL-15

    Measured: Up to 24 months

  21. Peak Serum Levels of Inflammatory and Immune Modulating Cytokines: IFN-γ, IL-1, IL-6, IL- 13, IL-17, IL-1, IL-1RA, Granulocyte-macrophage Colony Stimulating Factor (GM-CSF), Tumor Necrosis Factor-Alpha (TNF-α), and IL-12p40/p70

    IFN-γ=Interferon-Gamma, IL-1RA=IL-1 Receptor Antagonist

    Measured: Up to 24 months

  22. Peak Serum Levels of Immune Effector Molecules: Granzyme A, Granzyme B, and Perforin

    Measured: Up to 24 months

  23. Peak Serum Levels of the Acute Phase Response Proteins: C-Reactive Protein (CRP), Serum Amyloid A (SAA), Soluble IL-2 Receptor Alpha (sIL-1Ra), Ferritin

    Measured: Up to 24 months

  24. Peak Serum Levels of Chemokines: IL-8, C-X-C Motif Chemokine Ligand-10 (CXCL-10), and Monocyte Chemotactic Protein-1 (MCP-1)

    Measured: Up to 24 months

  25. Blood Levels of Axicabtagene Ciloleucel Chimeric Antigen Receptor (CAR) T-cells Over Time

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2022
  2. Study start9 Aug 2022
  3. Primary completion24 Nov 2025
  4. Study completion24 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05459571
Sponsor's protocol ID
KT-US-482-0137
Acronym
ZUMA-24
Status last verified
Jan 2026
First submitted
13 Jul 2022
Last updated
2 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment

Publications

  • Leslie LA, Baird JH, Flinn IW, Tees M, Hoda D, Deol A, Young P, McClune B, Varadarajan I, Essell J, Fanning S, Simmons G, Clark W, Rapoport AP, Rodriguez TE, Winters JN, Davis M, Miao HM, Ray M, Fang X, Kim JJ, Oluwole OO. Outpatient axicabtagene ciloleucel for relapsed/refractory large B-cell lymphoma: ZUMA-24 primary analysis. Am J Cancer Res. 2025 Aug 15;15(8):3417-3433. doi: 10.62347/GJNN1023. eCollection 2025.

    PubMed 40948517

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Axicabtagene Ciloleucel, Cyclophosphamide and Fludarabine in people with Relapsed or Refractory Large B-cell Lymphoma, run by Kite, A Gilead Company at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage and Severity of Participants with Treatment-emergent Cytokine Release Syndrome (CRS) and Neurologic Events (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05459571, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.

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