Study of Brexucabtagene Autoleucel (KTE-X19) for the Treatment of Individuals With Relapsed/Refractory B-Cell Malignancies (ZUMA-18)

October 6, 2021 updated by: Kite, A Gilead Company

A Multicenter, Open-label, Expanded Access Study of KTE-X19 for the Treatment of Subjects With Relapsed/Refractory B-Cell Malignancies

The primary objectives of this study are:

Cohort 1: to provide access to brexucabtagene autoleucel (KTE-X19) for individuals with relapsed or refractory (r/r) mantle cell lymphoma (MCL) until KTE-X19 is commercially available

Cohort 2: To provide access to KTE-X19 for individuals with r/r MCL whose commercially manufactured product did not meet commercial release specification(s)

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, expanded access study of KTE-X19 for the treatment of individuals with r/r B-cell malignancies. The study will consist of 2 cohorts as indicated below:

Cohort 1 will enroll individuals prior to commercial availability of KTE-X19 for the proposed indication.

Cohort 2 will enroll individuals after KTE-X19 becomes commercially available in cases when KTE-X19 does not meet commercial release specification(s).

The participants who received an infusion of KTE-X19 will be provided the opportunity to transition to a separate long-term follow-up (LTFU) study, KT-US-982-5968.

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford Cancer Institute
    • Colorado
      • Denver, Colorado, United States, 80218
        • Colorado Blood Cancer Institute
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center at Hackensack University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
      • Nashville, Tennessee, United States, 37232
        • Henry-Joyce Cancer Clinic
    • Texas
      • Houston, Texas, United States, 77030
        • The University of TX MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

Cohort 1:

  • Pathologically confirmed mantel cell lymphoma (MCL), with documentation of either overexpression of cyclin D1 or presence of t(11;14)

  • Received at least one prior regimen for MCL. Prior therapy must have included:

    • Anthracycline or bendamustine-containing chemotherapy, or
    • Anti-CD20 monoclonal antibody therapy, or
    • Treatment with Bruton's tyrosine kinase inhibitor (BTKi): ibrutinib, acalabrutinib, or a BTKi in a clinical trial for r/r MCL.

  • Relapsed or refractory disease, defined by the following:

    • Disease progression after last regimen, or
    • Failure to achieve a partial response (PR) or complete response (CR) to the last regimen
  • Magnetic resonance imaging (MRI) of the brain showing no evidence of central nervous system (CNS) lymphoma
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Absolute neutrophil count (ANC) ≥ 1,000/uL
  • Platelet count ≥ 75,000/uL
  • Absolute lymphocyte count ≥ 100/uL

  • Adequate renal, hepatic, pulmonary, and cardiac function defined as the following:

    • Creatinine clearance (as estimated by Cockcroft Gault formula) ≥ 60 cc/min
    • Serum alanine aminotransferase/aspartate aminotransferase (ALT)/AST) ≤ 2.5 x upper limit of normal (ULN)
    • Total bilirubin ≤ 1.5 mg/dl, except in individuals with Gilbert's syndrome
    • Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion (except trace or physiological) as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings
    • No clinically significant pleural effusion
    • Baseline oxygen saturation > 92% on room air
  • Females of childbearing potential must have a negative serum or urine pregnancy test. Females who have undergone surgical sterilization or who have been post-menopausal for at least 2 years are not considered to be of childbearing potential.
  • At least 1 measurable lesion. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy. If the only measurable disease is lymph node disease, at least 1 lymph node should be ≥ 2 cm.

Cohort 2:

  • Individuals whose commercial manufacture of KTE-X19 did not meet commercial release specification(s)

Key Exclusion Criteria:

Cohort 1:

  • Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management.
  • History of human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B or hepatitis C infection.
  • History of detectable cerebrospinal fluid (CSF) malignant cells or brain metastases or with a history of CNS lymphoma, CSF malignant cells, or brain metastases
  • History of CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with CNS involvement

Cohort 2:

  • Any medical condition that, as deemed by the treating physician, may interfere with assessment of safety or efficacy of study treatment

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kite, A Gilead Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 11, 2019

First Submitted That Met QC Criteria

November 11, 2019

First Posted (Actual)

November 14, 2019

Study Record Updates

Last Update Posted (Actual)

October 14, 2021

Last Update Submitted That Met QC Criteria

October 6, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KT-US-472-0118

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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