On October 17, 2023 CytoAgents, Inc., a clinical-stage biotechnology company developing a safe, effective treatment for Cytokine Release Syndrome (CRS), reported that it has initiated recruitment and will enroll its first patient at UPMC Hillman Cancer Center, in the Phase 1b/2a clinical trial evaluating the therapeutic, CTO1681, to treat CRS in lymphoma patients receiving CAR T-cell Therapy (Press release, CytoAgents, OCT 17, 2023, View Source [SID1234636060]).
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"This clinical trial (CTA-2101) addresses an area of great unmet medical need as the majority of patients receiving CAR T-cell Therapy experience the toxicities of CRS and associated neurotoxicity," said Arthur P. Bertolino, MD, PhD, MBA, Chief Medical Officer at CytoAgents.
The clinical trial will be conducted at multiple U.S. sites, with UPMC Hillman Cancer Center now the initial enrolling site. The trial investigates the safety, tolerability, and efficacy of different doses of CTO1681 in lymphoma patients receiving CAR T-cell therapy.
"We were early adopters of CAR T-cell therapy and remain committed to providing this treatment for our patients in the safest way possible," said Robert L. Ferris, M.D., Ph.D., a physician-scientist, and director of UPMC Hillman Cancer Center. "We are dedicated to solving the CRS problem associated with CAR T-cell therapy and to be a part of this clinical trial at our institution."
CytoAgents is developing innovative pharmaceutical products to treat life-threatening conditions, diseases and disorders associated with CRS, commonly referred to as cytokine storm. CRS is caused by excessive cytokine production and can be triggered by a range of diseases and treatments. Certain advanced immunotherapies in the oncology space such as CAR T-cell and Bispecific Antibody Therapies suffer from high incidence of associated CRS. The company expects that effective CRS management will support greater accessibility to and broader adoption of these highly effective therapies in the clinic.
"We are thrilled to advance CTO1681 into the clinic to establish key insights into the safety and efficacy of our novel therapeutic," said Teresa Whalen, RPh, CEO at CytoAgents. "Dosing our first patients in the lymphoma population is an important step forward for the company and the patients who may benefit. We look forward to continued enrollment with data anticipated in 2024."
Details of the CTA-2101 trial can be found at www.clinicaltrials.gov under the identifier NCT05905328.