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
You may not be if
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
Clareo Health | Axicabtagene Ciloleucel Expanded Access Study
