Study of KTE-X19 for the Treatment of Individuals With Relapsed/Refractory B-Cell Malignancies (ZUMA-18)
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Key Inclusion Criteria:
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, and
Anti-CD20 monoclonal antibody therapy, and
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 to 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:
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
Key Exclusion Criteria:
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.
Individuals with detectable cerebrospinal fluid (CSF) malignant cells or brain metastases or with a history of CNS lymphoma, CSF malignant cells, or brain metastases
History or presence 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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.