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

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ClinicalTrials.gov Identifier: NCT04162756
Expanded Access Status : Approved for marketing
First Posted : November 14, 2019
Last Update Posted : October 14, 2021
Information provided by (Responsible Party):
Gilead Sciences ( Kite, A Gilead Company )

Brief Summary:

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)

Condition or disease Intervention/treatment
Relapse/Refractory Mantle Cell Lymphoma Biological: Brexucabtagene Autoleucel (KTE-X19) Drug: Fludarabine Drug: Cyclophosphamide

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.

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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
Official Title: A Multicenter, Open-label, Expanded Access Study of KTE-X19 for the Treatment of Subjects With Relapsed/Refractory B-Cell Malignancies

Intervention Details:
  • Biological: Brexucabtagene Autoleucel (KTE-X19)
    A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg administered intravenously.
    Other Name: Tecartus™
  • Drug: Fludarabine
    Administered per package insert
  • Drug: Cyclophosphamide
    Administered per package insert

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04162756

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United States, California
Stanford Cancer Institute
Stanford, California, United States, 94305
United States, Colorado
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, New Jersey
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States, 37232
United States, Texas
The University of TX MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Kite, A Gilead Company
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Study Director: Kite Study Director Kite, A Gilead Company
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Responsible Party: Kite, A Gilead Company
ClinicalTrials.gov Identifier: NCT04162756    
Other Study ID Numbers: KT-US-472-0118
First Posted: November 14, 2019    Key Record Dates
Last Update Posted: October 14, 2021
Last Verified: October 2021
Additional relevant MeSH terms:
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Lymphoma, Mantle-Cell
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists