CytoAgents Inc., a clinical-stage biotechnology company developing CTO1681 for the prevention and treatment for Cytokine Release Syndrome (CRS), announced the successful completion of the first dose, core cohort dose-limiting toxicity observation period in its ongoing Phase 1b/2a clinical trial. Following a review of safety and efficacy data, the Safety Review Committee (SRC) has approved dose-escalation to the next, higher planned dose in Cohort 2.
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“This milestone marks an important step forward in our mission to deliver a safe, effective therapy for Cytokine Release Syndrome,” said Teresa Whalen, RPh, CEO of CytoAgents.
“This milestone marks an important step forward in our mission to deliver a safe, effective therapy for Cytokine Release Syndrome,” said Teresa Whalen, RPh, CEO of CytoAgents. “We remain focused on advancing through the next stages of this trial and ultimately delivering a much-needed treatment option for patients facing this life-threatening immune response.”
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The first-dosing cohort included patients with Diffuse Large B-Cell Lymphoma (DLBCL) receiving CAR T-Cell Therapy at risk for CRS. Current data from this cohort demonstrated a favorable safety profile, with no dose limiting toxicities (DLTs) or drug-related serious adverse events (SAEs) observed. Additionally, no interference with the CAR T-Cell Therapy was observed.
The trial, NCT05905328, is an open-label, dose-escalation, multi-center study designed to evaluate the safety, tolerability, and preliminary efficacy of CTO1681 in DLBCL patients receiving CAR T-Cell Therapy at risk for CRS. The trial follows a standard, rolling six dose-escalation design, with the goal of evaluating the safety profile, the pharmacokinetics of CTO1681, and determining the Recommended Phase 2 Dose (RP2D).
“The safety and early efficacy data from the first dose cohort are encouraging,” said Arthur P. Bertolino, MD, PhD, MBA, Chief Medical Officer of CytoAgents. “We look forward to evaluating the higher dose cohorts to further study the potential of CTO1681 to prevent and treat CRS, a very significant toxicity of CAR T-Cell Therapy.”
CTO1681 is an investigational new drug that uses a novel approach to prevent and mitigate Cytokine Release Syndrome in patients receiving CAR T-Cell Therapy. This is an area of significant unmet medical need, as the majority of patients undergoing CAR T-Cell Therapy for their cancer experience CRS and associated neurotoxicity.
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Source – businesswire
