Kiromic BioPharma has announced the activation of Virginia Oncology Associates as the second site for its Phase I Deltacel-01 clinical trial of allogeneic Gamma Delta T-cell (GDT) therapy, Deltacel (KB-GDT-01), targeting non-small cell lung cancer (NSCLC).
The company concluded the site initiation process at Virginia Oncology Associates and plans to commence enrolment of subjects with stage 4 metastatic NSCLC in April.
Trial initiation will be based on the analysis of preliminary data from the initial cohort comprising three patients.
Dr Gary Simmons will act as the trial’s principal investigator at this site.
In the open-label trial, stage 4 NSCLC patients will be given two intravenous doses of Deltacel, alongside four sessions of low-dose, localised radiation over ten days.
It’s primary goal is to assess safety, while secondary endpoints comprise progression-free survival, objective response, overall survival, time to progression, time to treatment response, and disease control rates.
The trial's progress comes after the third subject completed treatment at Beverly Hills Cancer Center in February.
Kiromic anticipates reporting the preliminary tolerability, safety, and efficacy findings from the first two patients by the end of March.
As the leading candidate in Kiromic’s GDT platform, Deltacel comprises unmodified, donor-derived gamma delta T cells.
It aims to harness the inherent power of GDT cells to combat solid cancers, with NSCLC as the initial clinical focus.
Preclinical research indicated a favourable safety and efficacy profile for Deltacel, especially when used in conjunction with low-dose radiation.
Kiromic BioPharma CEO Pietro Bersani said: “Virginia Oncology Associates is known for its excellence in oncology-focused research and patient care, and we are delighted to add them as the second Deltacel-01 clinical trial site.
“With encouraging preliminary results from the first patient in Deltacel-01, we are proud to expand trial access to more sites with the goal of enhancing enrolment efficiency and data quality.”
Earlier this year, Kiromic BioPharma reported ‘favourable’ data from the first subject in its Phase I clinical trial of Deltacel in treating stage 4 metastatic NSCLC.
