A Phase 2 Trial of Emapalumab for the Prevention of CAR-T Cell Associated Toxicities
This research study involves assessing the impact of emapalumab as preventative management of CAR-T related cytokine release syndrome in participants with Non-Hodgkin's lymphoma (NHL). The research study involves the following study interventions: * Fludarabine and cyclophosphamide (Lymphodepleting Chemotherapy) * Axicabtagene Ciloleucel * Emapalumab
• Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Or adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
• At least 1 measurable lesion per Lugano at time of screening.
• At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic inhibitory/stimulatory immune checkpoint therapy however steroids only require a 7-day washout.
• At least 3 half-lives must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy at the time the subject is planned for leukapheresis (e.g. ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc).
• Age 18 or older
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Adequate renal, hepatic, pulmonary and cardiac function defined as:
‣ ANC ≥1000/uL
⁃ Platelet count ≥50,000/uL
⁃ Absolute lymphocyte count ≥100/uL
⁃ Creatinine clearance (as estimated by Cockcroft Gault or CKD-EPI) ≥ 30 mL/min
⁃ Serum ALT/AST ≤2.5 per institutional ULN
⁃ Total bilirubin ≤1.5 mg/dl, except in subjects with Gilbert's syndrome.
⁃ Cardiac ejection fraction ≥ 40%, no clinically significant pericardial effusion, and no clinically significant ECG findings
⁃ 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 postmenopausal for at least 2 years are not considered to be of childbearing potential).
• Ability to understand and the willingness to sign a written informed consent document.