Kiromic BioPharma has announced interim results from Part 1 of its Phase I Deltacel-01 clinical trial of Deltacel (KB-GDT-01) in patients with stage four metastatic non-small cell lung cancer (NSCLC).
Deltacel is an off-the-shelf Gamma Delta T-cell (GDT) therapy.
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The open-label trial is designed to assess the safety and tolerability of two intravenous infusions of Deltacel with four courses of low-dose, localised radiation over a ten-day period in stage 4 NSCLC patients who have failed to respond to standard therapies.
The primary goal of the Deltacel-01 trial is to assess the safety of the treatment.
Secondary endpoints include measuring the progression-free survival (PFS), objective response, overall survival, time to treatment response, time to progression and disease control rates.
Data from five patients assessed for PFS showed a range from two to eight months, with an average of 4.8 months.
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By GlobalDataNotably, no dose-limiting toxicities (DLTs) were reported in subjects who completed the full therapy course.
One patient, however, was withdrawn from the trial due to an adverse event related to a pre-existing condition, which was not associated with Deltacel, and therefore could not be evaluated for PFS.
The sixth and final patient in Part 1 of the study commenced treatment on 6 August.
Kiromic anticipates early safety and tolerability results from this last enrolled patient in September this year, with efficacy outcomes expected in early October.
The company remains on schedule to begin Part 2 of the Deltacel-01 trial in September.
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.”
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