CytoAgents, Inc.
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 lymphoma or multiple myeloma who are scheduled to receive CAR T-cell therapy. The first phase of the study is open label with dose escalation. Participants will start taking CTO1681 either the day before starting lymphodepleting chemotherapy or just prior to receiving their CAR T-cell therapy, depending on their cohort assignment. In both cases participants will continue to take the study drug three times daily until 13 days after their CAR T-cell infusion.
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 wi…
Inclusion Criteria: 1. Age 18 years or older. 2. Undergone leukapheresis and is scheduled to receive protocol-specified CAR T-cell therapy (axicabtagene ciloleucel, lisocabtagene maraleucel, idecabtagene vicleucel, or ciltacabtagene autoleucel) for relapsed or refractory lymphoma or multiple myeloma. All patients must have relapsed or refractory disease to at least one prior line of systemic therapy. Prior CAR T-cell therapy is allowable with approval from the Sponsor and Medical Monitor. 3. Met all inclusion criteria for CAR T-cell therapy per institutional guidelines. 4. Adequate organ func…
Administered 3 times daily for 15 days (initial cohort).
Administered 3 times daily for 15 days (successive cohort).
Administered 3 times daily for 15 days (successive cohort).
Administered 3 times daily for up to 21 days (successive cohort).
Administered three times daily for up to 21 days (successive cohort).