Study of CTO1681 for the Prevention and Treatment of CRS in Patients Receiving CAR T-Cell Therapy

The first phase of the study will be an open-label, dose escalation, safety assessment in a group of patients, and will also collect data to investigate the potential benefit of CTO1681, initiated prior to CAR T-cell therapy, in preventing or reducing certain toxicities or side effects associated with CAR T-cell therapy, such as cytokine release syndrome (CRS). This study will enroll adult patients with lymphoma or multiple myeloma who are scheduled to receive commercially available, protocol specified CAR T-cell therapy. Participants who are assigned to cohorts not receiving run-in dosing will start taking CTO1681 the day prior to receiving their CAR T-cell therapy and continue to take the study drug three times daily until 13 days after the CAR T-cell infusion (total of 15 days). Participants assigned to cohorts the do receive run-in dosing will start taking CTO1681 the day before starting lymphodepleting chemotherapy and continue to take the study drug three times daily until 13 days after the CAR T-cell infusion (approximately 20 days total). Participants will provide blood samples at specified points throughout the study. In addition, urine samples, ECGs, scans, and other medical evaluations will be performed that are associated with the CAR T-cell therapy and/or necessary to verify study eligibility. Participants will be monitored for safety and efficacy from the start of dosing until 41 days after CAR T-cell infusion, and then will have follow-up to continue to monitor for safety and monitor for tumor response for up to 6 months for phase 1.