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NCT05905328 · ClinicalTrials.gov registry record · Phase 1
Study of CTO1681 for the Prevention and Treatment of CRS in DLBCL Patients Receiving CAR T-Cell Therapy
A Phase 1 study of Cytokine Release Syndrome, sponsored by CytoAgents.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
- 6
- Study locations
NCT05905328: Recruiting Phase 1 study of Cytokine Release Syndrome, sponsored by CytoAgents.
NCT05905328 is a Phase 1 study of Cytokine Release Syndrome that is actively recruiting participants, run by CytoAgents. The registered enrollment target is 54 participants, above the 30-participant average among 3 other Cytokine Release Syndrome trials with a reported enrollment target (80% higher). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05905328, a Phase 1 study of Cytokine Release Syndrome, is actively recruiting participants, sponsored by CytoAgents.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
AEs graded by CTCAE v5.0
Conditions Studied
Interventions
- DRUG CTO1681 10 μg
- DRUG CTO1681 20 μg
- DRUG CTO1681 30 μg
Study Locations (6)
California
- University of California, Irvine - Chao Family Comprehensive Cancer Center - Orange
Georgia
- Georgia Cancer Center at Augusta University - Augusta
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
North Carolina
- Duke Cancer Institute - Durham
Pennsylvania
- University of Pittsburgh Medical Center - Pittsburgh
Washington
- Fred Hutchinson Cancer Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2023-12-28 |
| Est. Completion | 2027-06 |
| Phase | Phase 1 |
What NCT05905328 shows while recruiting
NCT05905328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, above the 30-participant average among 3 other Cytokine Release Syndrome trials with a reported enrollment target (80% higher).
The record links to 1 condition, with Cytokine Release Syndrome appearing as the primary indexed condition, and to 3 interventions - of which CTO1681 10 μg is the first listed.
NCT05905328 lists 6 locations in 6 states (California, Georgia, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT05905328 about?
NCT05905328 is a clinical study titled "Study of CTO1681 for the Prevention and Treatment of CRS in DLBCL Patients Receiving CAR T-Cell Therapy". 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 w...
What is the current status of trial NCT05905328?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2023-12-28. Estimated completion is 2027-06.
What conditions does trial NCT05905328 study?
This clinical trial studies the following conditions: Cytokine Release Syndrome.
What interventions are being tested in trial NCT05905328?
The interventions under investigation include: CTO1681 10 μg (DRUG), CTO1681 20 μg (DRUG), CTO1681 30 μg (DRUG).
Who is sponsoring clinical trial NCT05905328?
This trial is sponsored by CytoAgents, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05905328 being conducted?
This trial has 6 study locations across California, Georgia, Massachusetts, North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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