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Study of CTO1681 for the Prevention and Treatment of CRS in Patients Receiving CAR T-Cell Therapy
Sponsor: CytoAgents, Inc.
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 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.
Official title: Phase 1B/2A Study of CTO1681 for the Prevention and Treatment of Cytokine Release Syndrome in Patients Receiving Chimeric Antigen Receptor T-Cell Therapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
54
Start Date
2023-12-28
Completion Date
2027-06
Last Updated
2026-08-31
Healthy Volunteers
No
Conditions
Interventions
CTO1681 10 µg
Administered 3 times daily for 15 days (initial cohort).
CTO1681 20 μg
Administered 3 times daily for 15 days (successive cohort).
CTO1681 30 μg
Administered 3 times daily for 15 days (successive cohort).
CTO1681 10 µg Run-in / 20 µg Treatment
Administered 3 times daily for up to 21 days (successive cohort).
CTO1681 20 µg Run-in / 30 µg Treatment
Administered three times daily for up to 21 days (successive cohort).
Locations (6)
University of California, Irvine - Chao Family Comprehensive Cancer Center
Orange, California, United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Duke Cancer Institute
Durham, North Carolina, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States