Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
A multicenter, open-label expanded access protocol for the treatment of subjects with
relapsed/refractory large B-cell lymphoma.
Subjects who received an infusion of KTE-X19 will complete the remainder of the 15 year
follow-up assessments in a separate long-term follow-up study, KT-US-982-5968
Phase
N/A
Funding Agency/Sponsor
Industrial
Disease
Lymphoma
Enrollment Eligibility
Inclusion Criteria:
1. Histologically confirmed large B-cell lymphoma, including the following types:
1. DLBCL, not otherwise specified
2. Primary mediastinal large B-cell lymphoma
3. High-grade B-cell lymphoma
4. DLBCL arising from follicular lymphoma (transformed follicular lymphoma, or TFL)
2. Relapsed or refractory disease, defined as one or more of the following:
1. No response to first-line therapy (primary refractory disease); subjects who are
intolerant to first-line therapy chemotherapy are excluded OR
2. No response or relapse to second or greater lines of therapy OR
3. Relapsed after ASCT
3. Subjects must have received adequate prior therapy including at a minimum:
1. anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20
negative, and
2. an anthracycline containing chemotherapy regimen;
4. No evidence, suspicion, and/or history of central nervous system (CNS) involvement of
lymphoma
5. Age 18 or older
6. Eastern cooperative oncology group (ECOG) performance status of 0 or 1
7. Absolute neutrophil count ANC ≥1000/μL
8. Platelet count ≥75,000/μL
9. Absolute lymphocyte count ≥100/μL
10. Adequate renal, hepatic, pulmonary and cardiac function defined as:
1. Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min
2. Serum alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤2.5 upper
limit of normal (ULN)
3. Total bilirubin ≤1.5 mg/dL, except in subjects with Gilbert's syndrome.
4. Cardiac ejection fraction ≥ 50% and no evidence of pericardial effusion within
180 days provide the subject did not receive an anthracycline based treatment or
experience a cardiac event or change in performance status
5. No clinically significant pleural effusion
6. Baseline oxygen saturation >92% on room air
11. Cohort 2 inclusion criteria: Subjects whose commercial manufacture of axicabtagene
ciloleucel did not meet commercial release specification(s)
Exclusion Criteria:
1. History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g.
cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3
years
2. History of allogeneic stem cell transplantation (SCT)
3. Prior CD19 targeted therapy
4. Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy
5. History of severe, immediate hypersensitivity reaction attributed to aminoglycosides
6. Presence or suspicion of fungal, bacterial, viral, or other infection that is
uncontrolled or requiring intravenous (IV) antimicrobials for management. Simple
urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if
responding to active treatment and after consultation with the Kite Pharma Medical
Monitor
7. History of human immunodeficiency virus (HIV) infection or acute or chronic active
hepatitis B or hepatitis C infection. Subjects with a history of hepatitis infection
must have cleared their infection as determined by standard serological and genetic
testing per current Infectious Diseases Society of America (IDSA) guidelines
8. History or presence of primary CNS lymphoma and/or CNS disorder such as seizure
disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any
autoimmune disease with CNS involvement
9. Cohort 2 exclusion criteria: Any medical condition that, deemed by the investigator,
may interfere with assessment of safety or efficacy of study treatment