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

NCT05459571 | Completed Phase 2 FDA Drug

• 1 other identifier: KT-US-482-0137
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Relapsed or Refractory Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

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

  Up to 24 months

Secondary Outcomes (25)

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

  First infusion date of axicabtagene ciloleucel up to 24 months

• Duration of CRS and Neurologic Events Following Axicabtagene Ciloleucel Administration

  First infusion date of axicabtagene ciloleucel up to 24 months

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

  First infusion date of axicabtagene ciloleucel up to 72 hours

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

  First infusion date of axicabtagene ciloleucel up to 3 days

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

  First infusion date of axicabtagene ciloleucel up to 7 days

Study Arms (1)

Axicabtagene Ciloleucel

EXPERIMENTAL

Participant 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.

Biological: Axicabtagene Ciloleucel; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Dexamethasone

Interventions

Axicabtagene Ciloleucel BIOLOGICAL

Administered intravenously

Also known as: Yescarta®

Axicabtagene Ciloleucel

Cyclophosphamide DRUG

Administered intravenously

Axicabtagene Ciloleucel

Fludarabine DRUG

Administered intravenously

Axicabtagene Ciloleucel

Dexamethasone DRUG

Administered orally or intravenously

Axicabtagene Ciloleucel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kite, A Gilead Company: lead

Study Sites (16)

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

Duarte, California, 91010, United States

Location

UCLA

Los Angeles, California, 90025, United States

Location

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Oncology Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, 45242, United States

Location

Prisma Health - Upstate

Greenville, South Carolina, 29615, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

Henry-Joyce Cancer Clinic

Nashville, Tennessee, 37232, United States

Location

Methodist Healthcare System of San Antonio

San Antonio, Texas, 78229, United States

Location

Intermountain Healthcare

Murray, Utah, 84107, United States

Location

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84112, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

Related Publications (1)

• 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.

  PMID: 40948517 DERIVED

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Recurrence

Interventions

axicabtagene ciloleucel; Cyclophosphamide; fludarabine; Dexamethasone

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Kite Study Director

  Kite, A Gilead Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 15, 2022
• Study Start: August 9, 2022
• Primary Completion: November 24, 2025
• Study Completion: November 24, 2025
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.

Locations

US (16)