Kiromic BioPharma, a clinical-stage biotherapeutics company, has reported interim results from Part 1 of its Deltacel-01 Phase I clinical trial.
The trial is assessing the safety and tolerability of allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy Deltacel (KB-GDT-01) in patients with stage 4 metastatic non-small cell lung cancer (NSCLC).
Under the trial, patients, who have failed to respond to standard therapies, would receive two intravenous infusions of Deltacel with four courses of low-dose, localised radiation over a ten-day period.
Deltacel-01 also includes determining progression-free survival (PFS), overall survival, time to progression, time to treatment response and disease control rates as secondary endpoints.
The PFS ranged from two to eight months, with an average of 4.8 months, according to the data received after assessing five patients in the long-term follow-up.
The clinical site has also reported no dose limiting toxicities (DLTs) for patients who underwent the full course of therapy.
One patient withdrew from the study before completion of the full course of therapy due to an adverse event unrelated to Deltacel, the company said.
The final patient in Part 1 of the Deltacel-01 study began treatment last week. Kiromic expects to receive safety and tolerability outcomes next month and efficacy results in early October.
Kiromic BioPharma CEO Pietro Bersani said: “We are pleased to have completed enrolment in Part 1 of our clinical trial.
“The favourable results of our GDT therapy, particularly with respect to PFS, in the first two cohorts that comprise Part 1 underscore the potential of Deltacel to treat solid tumours, and we look forward to launching Part 2 of this study.”
The company is slated to start Part 2 of Deltacel-01 in September.
