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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 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.

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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.

Conditions Studied

Cytokine Release Syndrome

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

FieldValue
Enrollment Target 54 participants
Start Date 2023-12-28
Est. Completion 2027-06
Phase Phase 1

Sponsor

CytoAgents

1 total trials

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What the Registry Record Tells You About NCT05905328

The ClinicalTrials.gov registry entry for NCT05905328 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 30-participant average among 3 other Cytokine Release Syndrome trials with a reported enrollment target (80% higher). The listed sponsor is CytoAgents, which has 1 total studies on file at ClinicalTrials.gov.

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 reports 6 study locations spanning 6 distinct geographic areas - top geographies include 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.