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

Primary Purpose

Relapse/Refractory Mantle Cell Lymphoma

Status
Approved for marketing
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Brexucabtagene Autoleucel (KTE-X19)
Fludarabine
Cyclophosphamide
Sponsored by
Kite, A Gilead Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Relapse/Refractory Mantle Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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.

Sites / Locations

  • Stanford Cancer Institute
  • Colorado Blood Cancer Institute
  • Moffitt Cancer Center
  • Dana-Farber Cancer Institute
  • John Theurer Cancer Center at Hackensack University Medical Center
  • Cleveland Clinic
  • Sarah Cannon Research Institute
  • Henry-Joyce Cancer Clinic
  • The University of TX MD Anderson Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 11, 2019
Last Updated
October 6, 2021
Sponsor
Kite, A Gilead Company
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1. Study Identification

Unique Protocol Identification Number
NCT04162756
Brief Title
Study of Brexucabtagene Autoleucel (KTE-X19) for the Treatment of Individuals With Relapsed/Refractory B-Cell Malignancies
Acronym
ZUMA-18
Official Title
A Multicenter, Open-label, Expanded Access Study of KTE-X19 for the Treatment of Subjects With Relapsed/Refractory B-Cell Malignancies
Study Type
Expanded Access

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Approved for marketing
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kite, A Gilead Company

4. Oversight

5. Study Description

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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapse/Refractory Mantle Cell Lymphoma

7. Study Design

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kite Study Director
Organizational Affiliation
Kite, A Gilead Company
Official's Role
Study Director
Facility Information:
Facility Name
Stanford Cancer Institute
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Henry-Joyce Cancer Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
The University of TX MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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