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.
Age 18 years or older.
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.
Met all inclusion criteria for CAR T-cell therapy per institutional guidelines.
Estimated Creatinine Clearance per Cockroft Gault formula ≥ 60 mL/min.
Any cytotoxic chemotherapy within 14 days prior to leukapheresis.
Clinically significant malabsorption syndromes and swallowing difficulties which are inadequately controlled with medication (eg, odynophagia, dysphagia, gastroesophageal reflux disease) as per Investigator assessment.
Potassium < 3.0 or > 5.5 mmol/L
Sodium < 130 or > 150 mmol/L
CytoAgents, Inc.
Lead sponsor