Study of CTO1681 for the Prevention and Treatment of CRS in DLBCL Patients Receiving CAR T-Cell Therapy
Trial Parameters
Brief Summary
This is an interventional study to evaluate the use of CTO1681 in preventing or reducing CAR T-cell-induced toxicities like cytokine release syndrome (CRS). This study will enroll adult patients with DLBCL who are scheduled to receive CD19-directed CAR T-cell therapy. The first phase of the study will be open label with dose escalation. Participants will start taking CTO1681 just prior to receiving their CAR T-cell therapy and continue to take the study drug three times daily for a total of 15 days.
Eligibility Criteria
Inclusion Criteria: 1. Age 18 years or older. 2. Undergone leukapheresis and is scheduled to receive protocol-specified commercially available CD19-directed CAR T-cell therapy (axicabtagene ciloleucel or lisocabtagene maraleucel) for DLBCL without corticosteroid prophylaxis for CRS and/or ICANS. Patients eligible for study must have relapsed or refractory DLBCL after at least one prior line of systemic therapy. 3. Met all inclusion criteria for CAR T-cell therapy per institutional guidelines. 4. Adequate organ function defined as: 1. Estimated Creatinine Clearance per Cockroft Gault formula ≥ 60 mL/min. 2. Serum alanine aminotransferase/aspartate aminotransferase ≤ 2.5 × ULN. 3. Total bilirubin ≤ 1.5 × ULN. 4. Left ventricular ejection fraction ≥ 40% on echocardiogram or multigated acquisition and no clinically significant pericardial effusion. 5. Platelets ≥ 50,000/mm3. 6. Absolute neutrophil count \> 1000/μL. 7. Absolute lymphocyte count \> 100/μL. 5. Documented measurable lymphoma d