Anakinra for the Prevention of Cytokine Release Syndrome and Neurotoxicity in Patients with B-Cell Non-Hodgkin Lymphoma Receiving CD19-Targeted CAR-T Cell Therapy

Inclusion Criteria

• Subjects must be 18 years of age or older
• Karnofsky performance status of >= 60%
• Patients with B-NHL and eligible for treatment with liso-cel. Patients treated with non-conforming (out-of-specification) liso-cel may remain on study
• Negative serum pregnancy test within 2 weeks of enrollment for women of childbearing potential, defined as those who have not been surgically sterilized or who have not been free of menses for at least 1 year
• Fertile male and female subjects must be willing to use an effective contraceptive method before, during, and for at least 4 months after the last dose of anakinra
• Ability to understand and provide informed consent

Exclusion Criteria

• Subjects requiring ongoing daily corticosteroid therapy at a dose of > 15 mg of prednisone per day (or equivalent). Pulsed corticosteroid use for disease control is acceptable
• Active autoimmune disease requiring immunosuppressive therapy is excluded unless discussed with the principal investigator (PI)
• Known hypersensitivity to Escherichia (E) coli-derived proteins, anakinra, or to any component of the product
• Serum creatinine > 2.5 mg/dL
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 5 x upper limit of normal
• Bilirubin > 3.0 mg/dL unless due to malignancy or Gilbert’s syndrome in the opinion of the PI or designee
• Subjects with clinically significant pulmonary dysfunction, as determined by medical history and physical exam should undergo pulmonary function testing. Those with a forced expiratory volume in 1 second (FEV1) of < 50% of predicted or diffusion capacity of the lung for carbon monoxide (DLCO) (corrected) < 40% will be excluded
• Significant cardiovascular abnormalities as defined by any one of the following: New York Heart Association (NYHA) class III or IV congestive heart failure, clinically significant hypotension, uncontrolled symptomatic coronary artery disease, or a documented ejection fraction of < 35%
• Uncontrolled serious and active infection