Phase 1B/2A Study of CTO1681 for the Prevention and Treatment of Cytokine Release Syndrome in Patients With Diffuse Large B-Cell Lymphoma Receiving Chimeric Antigen Receptor T-Cell Therapy
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 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.
Description
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). 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. Participants will provide blood samples at specified points througho…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 formu…
Interventions
- DrugCTO1681 10 μg
Administered 3 times daily for 15 days (initial cohort).
- DrugCTO1681 20 μg
Administered 3 times daily for 15 days (successive cohort).
- DrugCTO1681 30 μg
Administered 3 times daily for 15 days (successive cohort).
Locations (6)
- University of California, Irvine - Chao Family Comprehensive Cancer CenterOrange, California
- Georgia Cancer Center at Augusta UniversityAugusta, Georgia
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Duke Cancer InstituteDurham, North Carolina
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania
- Fred Hutchinson Cancer CenterSeattle, Washington