RecruitingPhase 1Phase 2NCT05905328

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


Sponsor

CytoAgents, Inc.

Enrollment

54 participants

Start Date

Dec 28, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called CTO1681 to see if it can prevent or reduce cytokine release syndrome (CRS) — a dangerous inflammatory reaction — in people with a type of blood cancer called diffuse large B-cell lymphoma (DLBCL) who are receiving CAR T-cell therapy (a form of immunotherapy). **You may be eligible if...** - You are 18 or older with relapsed or refractory DLBCL - You are scheduled to receive a specific commercial CAR T-cell therapy (axicabtagene ciloleucel or lisocabtagene maraleucel) - You have adequate heart, kidney, and liver function - You are able to take oral medications **You may NOT be eligible if...** - You have had a recent heart attack or stroke (within 6 months) - You have significant heart rhythm problems or require blood thinners at a therapeutic dose - You have uncontrolled blood pressure below 100 mmHg - You have an autoimmune disease that required immune-suppressing treatment in the past 2 years - You have significant electrolyte imbalances (such as low potassium or sodium) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 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

View Full Details on ClinicalTrials.gov

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NCT05905328


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