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RECRUITING
NCT05905328
PHASE1/PHASE2

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

Sponsor: CytoAgents, Inc.

View on ClinicalTrials.gov

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 lymphoma or multiple myeloma who are scheduled to receive CAR T-cell therapy. The first phase of the study is open label with dose escalation. Participants will start taking CTO1681 either the day before starting lymphodepleting chemotherapy or just prior to receiving their CAR T-cell therapy, depending on their cohort assignment. In both cases participants will continue to take the study drug three times daily until 13 days after their CAR T-cell infusion.

Official title: Phase 1B/2A Study of CTO1681 for the Prevention and Treatment of Cytokine Release Syndrome in Patients Receiving Chimeric Antigen Receptor T-Cell Therapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2023-12-28

Completion Date

2027-06

Last Updated

2026-08-31

Healthy Volunteers

No

Interventions

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).

DRUG

CTO1681 10 µg Run-in / 20 µg Treatment

Administered 3 times daily for up to 21 days (successive cohort).

DRUG

CTO1681 20 µg Run-in / 30 µg Treatment

Administered three times daily for up to 21 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