Kiromic BioPharma has reported early efficacy findings from the second participant in the Phase I Deltacel-01 clinical trial of Deltacel (KB-GDT-01) for stage 4 metastatic non-small cell lung cancer (NSCLC).
This patient demonstrated stabilisation of the primary lung tumour, as well as the complete disappearance of brain metastases.
Deltacel is an investigational, allogeneic, off-the-shelf gamma delta T-cell (GDT) therapy.
The open-label trial is designed to assess the safety and tolerability of Gamma Delta T Cell Infusions, plus low-dose radiotherapy, in stage 4 metastatic NSCLC patients.
Trial subjects will receive two intravenous infusions of Deltacel, plus four courses of low-dose, localised radiation for ten days.
While the primary objective of the trial is to assess safety, secondary measurements include objective response, progression-free survival, overall survival, time to progression, time to treatment response, and disease control rates.
According to the initial results obtained six weeks from the commencement of treatment, Deltacel showed efficacy in controlling tumour growth, with a favourable safety and tolerability profiles.
Stable disease status was also confirmed by CT scan.
An MRI scan of the brain performed before the commencement of treatment showed new onset metastatic disease, which completely resolved in repeat MRI imaging conducted six weeks from the start of treatment.
Kiromic plans to announce preliminary tolerability, safety, and efficacy results from the third subject enrolled in the trial by the end of this month.
Kiromic BioPharma CEO Pietro Bersani said: “These six-week results in the second patient enrolled in Deltacel-01 are extremely promising.
“Along with preliminary results from the first patient we previously reported, they strengthen the candidacy of Deltacel as a potential treatment for patients with advanced disease.
“The complete eradication of this patient’s preexisting brain metastases supports a growing body of evidence for the benefit of our therapy and could also support Deltacel-01 crossing the blood-brain barrier.”
The latest development comes after the company announced the activation of Virginia Oncology Associates as the second site for the Deltacel-01 trial of Deltacel in NSCLC patients.
