NCT05905328

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: CytoAgents, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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 for 43 days, 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.

Conditions

• Cytokine Release Syndrome

Interventions

Type	Name	Description
DRUG	CTO1681 10 μg	Administered 3 times daily for 15 days (initial cohort).
DRUG	CTO1681 20 μg	Administered 3 times daily for 15 days (successive cohort).
DRUG	CTO1681 30 μg	Administered 3 times daily for 15 days (successive cohort).

Timeline

• Start date: 2023-12-28
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2023-06-15
• Last updated: 2026-04-17

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study