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

Active:	Yes
Cancer Type:	Hematopoietic Malignancies Lymphoma Non-Hodgkin Lymphoma Unknown Primary	NCT ID:	NCT05905328
Trial Phases:	Phase I Phase II	Protocol IDs:	CTA-2101 (primary) NCI-2023-09252
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	CytoAgents, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05905328

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.

Objectives

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.

Treatment Sites in Georgia

Georgia Cancer Center at Augusta University
1411 Laney Walker Boulevard
Augusta, GA 30912
www.augusta.edu/cancer/

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