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


Study First Submitted Date 2019-11-11
Study First Posted Date 2019-11-14
Last Update Posted Date 2021-10-14
Verification Month Year October 2021
Verification Date 2021-10-31
Last Update Posted Date 2021-10-14

Detailed Descriptions

Sequence: 20752723
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.


Sequence: 200368231 Sequence: 200368232 Sequence: 200368233 Sequence: 200368234 Sequence: 200368235 Sequence: 200368236 Sequence: 200368237 Sequence: 200368238 Sequence: 200368239
Name Stanford Cancer Institute Name Colorado Blood Cancer Institute Name Moffitt Cancer Center Name Dana-Farber Cancer Institute Name John Theurer Cancer Center at Hackensack University Medical Center Name Cleveland Clinic Name Sarah Cannon Research Institute Name Henry-Joyce Cancer Clinic Name The University of TX MD Anderson Cancer Center
City Stanford City Denver City Tampa City Boston City Hackensack City Cleveland City Nashville City Nashville City Houston
State California State Colorado State Florida State Massachusetts State New Jersey State Ohio State Tennessee State Tennessee State Texas
Zip 94305 Zip 80218 Zip 33612 Zip 02215 Zip 07601 Zip 44195 Zip 37203 Zip 37232 Zip 77030
Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States

Browse Interventions

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Mesh Term Cyclophosphamide Mesh Term Fludarabine Mesh Term Brexucabtagene autoleucel Mesh Term Immunosuppressive Agents Mesh Term Immunologic Factors Mesh Term Physiological Effects of Drugs Mesh Term Antirheumatic Agents Mesh Term Antineoplastic Agents, Alkylating Mesh Term Alkylating Agents Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Antineoplastic Agents Mesh Term Myeloablative Agonists Mesh Term Antineoplastic Agents, Immunological
Downcase Mesh Term cyclophosphamide Downcase Mesh Term fludarabine Downcase Mesh Term brexucabtagene autoleucel Downcase Mesh Term immunosuppressive agents Downcase Mesh Term immunologic factors Downcase Mesh Term physiological effects of drugs Downcase Mesh Term antirheumatic agents Downcase Mesh Term antineoplastic agents, alkylating Downcase Mesh Term alkylating agents Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term antineoplastic agents Downcase Mesh Term myeloablative agonists Downcase Mesh Term antineoplastic agents, immunological
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor


Sequence: 52250547
Name Relapse/Refractory Mantle Cell Lymphoma
Downcase Name relapse/refractory mantle cell lymphoma

Id Information

Sequence: 40216593
Id Source org_study_id
Id Value KT-US-472-0118


Sequence: 42631482
Name United States
Removed False


Sequence: 52563593 Sequence: 52563594 Sequence: 52563592
Intervention Type Drug Intervention Type Drug Intervention Type Biological
Name Fludarabine Name Cyclophosphamide Name Brexucabtagene Autoleucel (KTE-X19)
Description Administered per package insert Description Administered per package insert Description A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg administered intravenously.

Browse Conditions

Sequence: 193790535 Sequence: 193790536 Sequence: 193790537 Sequence: 193790538 Sequence: 193790539 Sequence: 193790540 Sequence: 193790541 Sequence: 193790542 Sequence: 193790543
Mesh Term Lymphoma, Mantle-Cell Mesh Term Neoplasms Mesh Term Lymphoma, Non-Hodgkin Mesh Term Lymphoma Mesh Term Neoplasms by Histologic Type Mesh Term Lymphoproliferative Disorders Mesh Term Lymphatic Diseases Mesh Term Immunoproliferative Disorders Mesh Term Immune System Diseases
Downcase Mesh Term lymphoma, mantle-cell Downcase Mesh Term neoplasms Downcase Mesh Term lymphoma, non-hodgkin Downcase Mesh Term lymphoma Downcase Mesh Term neoplasms by histologic type Downcase Mesh Term lymphoproliferative disorders Downcase Mesh Term lymphatic diseases Downcase Mesh Term immunoproliferative disorders Downcase Mesh Term immune system diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor


Sequence: 48393891
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Kite, A Gilead Company

Overall Officials

Sequence: 29328584
Role Study Director
Name Kite Study Director
Affiliation Kite, A Gilead Company


Sequence: 30811718
Gender All
Minimum Age 18 Years
Maximum Age N/A
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.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254046235
Number Of Facilities 9
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility True
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years

Intervention Other Names

Sequence: 26710251
Intervention Id 52563592
Name Tecartus™

Responsible Parties

Sequence: 28924081
Responsible Party Type Sponsor