Kiromic BioPharma is advancing its Deltacel-01 clinical trial into the dose expansion phase after receiving unanimous approval from the Safety Monitoring Committee (SMC). The Phase 1/2 trial is evaluating KB-GDT-01 (Deltacel), an allogeneic gamma delta T-cell (GDT) therapy, for patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies. The trial's expansion phase is set to include approximately nine new patients and will further assess the effectiveness of Deltacel treatment.
Favorable Safety Profile and Early Efficacy Signals
The SMC's decision was based on a review of safety data from the trial's first two cohorts, which demonstrated a positive safety and tolerability profile for Deltacel. Notably, no dose-limiting toxicities were observed in the sixth patient after a 40-day follow-up. Interim data from the Deltacel-01 trial indicates a median progression-free survival (PFS) of 6 months across all treated patients, with a median follow-up time of 7.7 months.
Afshin Eli Gabayan, MD, Medical Director and Principal Investigator of Deltacel-01 at Beverly Hills Cancer Center, noted, "The follow-up results we are seeing in the Deltacel-01 trial are encouraging, especially for patients with limited treatment options. The stabilization of disease, combined with early signs of tumor reduction in some cases, speaks to the potential of this therapy to make an impact in the treatment of advanced solid tumors."
Promising Results in First Treated Patient
Kiromic reported favorable 10-month follow-up results from the first patient treated in the Deltacel-01 trial. The patient experienced an approximate 27% reduction in tumor size compared to baseline, with no new sites of disease identified. This resulted in a progression-free survival of 10 months without any reported adverse events. Earlier assessments at 6 and 8 months post-treatment showed tumor size reductions of approximately 13% and 20%, respectively.
Pietro Bersani, CEO of Kiromic BioPharma, stated, "As this patient is the most advanced in our ongoing Deltacel-01 clinical trial, we are particularly encouraged by these latest follow-up results that continue to validate the potential of Deltacel as a safe and effective treatment for patients with later-stage cancers. We believe these findings underscore the promise of our allogeneic GDT therapy in providing durable clinical benefit."
Deltacel's Mechanism and Trial Design
Deltacel (KB-GDT-01) is an investigational allogeneic gamma delta T-cell therapy designed to exploit the natural potency of GDT cells to target solid cancers. The Deltacel-01 trial (NCT06069570) is an open-label Phase 1 study evaluating the safety and tolerability of Deltacel infusions in combination with low-dose radiotherapy in patients with stage 4 metastatic NSCLC. Patients receive two intravenous infusions of Deltacel with four courses of low-dose, localized radiation over a 10-day period. Secondary outcome measures include objective response, progression-free survival, overall survival, time to progression, time to treatment response, and disease control rates.
Expansion and Future Plans
Kiromic has been actively expanding the Deltacel-01 trial to multiple clinical sites, including the University of Arizona Cancer Center, Virginia Oncology Associates, PC, and the University of Pittsburgh School of Medicine, to facilitate patient enrollment. The company anticipates a solid cadence of patient enrollment as it moves forward with the expansion phase of the trial.
