US-based biotherapeutics company Kiromic BioPharma has reported ‘favourable’ data from the first subject in its Phase I clinical trial of the gamma delta T-cell (GDT) therapy Deltacel.
The open-label Deltacel-01 trial is evaluating Deltacel’s efficacy in treating Stage IV metastatic non-small cell lung cancer (NSCLC).
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It is intended to assess the tolerability and safety of GDT infusions plus low-dose radiotherapy in Stage IV NSCLC patients.
Participants will be given two intravenous doses of Deltacel alongside four courses of low-dose, localised radiation for ten days.
The study’s primary goal is to evaluate Deltacel’s safety, while its secondary measurements include objective response, overall survival, progression-free survival, time to treatment response, time to progression and disease control rates.
According to early efficacy data, Deltacel was effective in controlling the growth of NSCLC and continued to be well-tolerated, reinforcing previously reported safety findings.
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By GlobalDataThe first trial subject was enrolled at the Beverly Hills Cancer Center and was confirmed to have an actively progressing disease just three days before starting the treatment.
A CT scan conducted six weeks after treatment showed disease stabilisation, suggesting an initial progression-free survival of one and a half months.
Kiromic BioPharma said it will issue updates as data is collected from ongoing monitoring activities and as more participants are enrolled in the trial.
Two preclinical studies have already demonstrated Deltacel’s safety and efficacy when used in conjunction with low-dose radiation.
Kiromic BioPharma CEO Pietro Bersani said: “We are delighted to share these best-case scenarios, preliminary efficacy results following recently announced favourable safety and tolerability data in this patient.
“Our initial results with Deltacel offer a glimpse of hope and are a testament to our dedication to improving patient outcomes with this challenging disease.
“We look forward to sharing more detailed data as our trial progresses and remain committed to the rigorous investigation of Deltacel’s potential in treating NSCLC.”
Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva.
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