CytoAgents has initiated recruitment in a Phase Ib/IIa clinical trial of CTO1681 to treat cytokine release syndrome (CRS) in lymphoma patients receiving CAR T-cell Therapy.
The study will be carried out at several US sites, with UPMC Hillman Cancer Center being the first site for enrolment.
It will assess the efficacy, tolerability, and safety of different doses of CTO1681.
The study’s first phase will be an open-label and dose escalation phase. Patients will be given CTO1681 10μg before receiving their CAR T-cell therapy.
They will continue to receive the drug three times daily for a total of 15 days.
Throughout the study, patients will provide blood samples at specified points and will undergo urine samples, ECGs, scans, and other medical evaluations.
They will be monitored for safety and efficacy for 43 days, and then have follow-up checks to continue to monitor for safety and tumour response for up to six months.
In the Phase II study, CTO1681 20μg and 30μg will be given three times a day for 15 days.
CytoAgents CEO Teresa Whalen said: “We are thrilled to advance CTO1681 into the clinic to establish key insights into the safety and efficacy of our novel therapeutic.
“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 enrolment, with data anticipated in 2024.”
The company is also engaged in developing bispecific antibody therapies and providing accessible treatment for Covid-19 and respiratory epidemics.
