Kiromic BioPharma has dosed the first subject in the Phase I Deltacel-01 clinical trial of its investigational gamma delta T-cell (GDT) therapy, Deltacel, to treat stage 4 metastatic non-small cell lung cancer (NSCLC).
The first patient was dosed at the Beverly Hills Cancer Center (BHCC) in the US.
The open-label trial is designed to analyse the safety and tolerability of Deltacel infusions along with low-dose radiotherapy.
Trial subjects will be given two intravenous doses of the therapy along with four courses of low-dose, localised radiation for ten days.
Assessing safety is the trial’s primary objective while progression-free survival, objective response, overall survival, time to treatment response, time to progression and disease control rates are included as the secondary goals.
The company plans to report preliminary safety and tolerability findings from the first subject by the end of this year.
Initial efficacy data will be reported by the end of January next year.
Furthermore, Kiromic plans to advance the trial to two more trial centres with enrolment expected to commence early next year.
Beverly Hills Cancer Center radiation oncologist and the trial’s sub-investigator Dr Arash Gabayan said: “The first course of combination of Deltacel and low dose radiation was successfully delivered to this first patient.
“Our clinical research team will continue monitoring this patient closely as we seek to understand how this innovative and exciting dual approach may impact the immune response against the cancer cells."
An allogeneic product, Deltacel comprises unmodified gamma delta T cells obtained from the donor.
It was created to utilise the GDT cells’ capability to act on solid cancers.
According to findings from two preclinical studies, Deltacel was shown to have encouraging efficacy and safety profile when used along with low-dose radiation.
Kiromic BioPharma CEO Pietro Bersani said: “We are extremely proud to initiate this first-in-human trial of Deltacel when we stated we would.
“Non-small cell lung cancer represents a significant unmet medical need, and a leading cause of death in the US.
“We look forward to enrolling additional patients to advance the clinical development of Deltacel for the treatment of solid tumours, starting with NSCLC.”
