Study of Brexucabtagene Autoleucel (KTE-X19) for the Treatment of Individuals With Relapsed/Refractory B-Cell Malignancies
ZUMA-18
A Multicenter, Open-label, Expanded Access Study of KTE-X19 for the Treatment of Subjects With Relapsed/Refractory B-Cell Malignancies
1 other identifier
expanded_access
N/A
1 country
9
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2019
CompletedFirst Posted
Study publicly available on registry
November 14, 2019
CompletedOctober 14, 2021
October 1, 2021
November 11, 2019
October 6, 2021
Conditions
Interventions
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg administered intravenously.
Administered per package insert
Administered per package insert
Eligibility Criteria
You may qualify if:
- 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:
- +10 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Stanford Cancer Institute
Stanford, California, 94305, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232, United States
The University of TX MD Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kite Study Director
Kite, A Gilead Company
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2019
First Posted
November 14, 2019
Last Updated
October 14, 2021
Record last verified: 2021-10