Kiromic BioPharma is reporting encouraging efficacy results from its ongoing Deltacel-01 Phase 1 clinical trial, evaluating Deltacel™ (KB-GDT-01) in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies. The data highlights the potential of allogeneic gamma delta T-cell therapy in treating advanced lung cancer.
Deltacel-01 Trial: Key Findings
Data from the Deltacel-01 trial indicate notable tumor volume reduction and progression-free survival in treated patients. Specifically, the first patient in the trial demonstrated a 33.33% reduction in tumor volume at the 12-month post-treatment follow-up, achieving a partial response. This was defined as a 30% or greater decrease in the size of the tumor. Furthermore, the fourth patient exhibited a partial response at the eight-month follow-up, with continued disease stabilization extending progression-free survival (PFS) to 10 months as of January 2025.
In addition, the seventh patient in the Deltacel-01 trial showed a 9.5% reduction in tumor size at the two-month follow-up visit. All three patients were treated at the Beverly Hills Cancer Center (BHCC).
Expert Commentary
Pietro Bersani, Chief Executive Officer of Kiromic BioPharma, stated, "The sustained, positive results we are seeing with the Deltacel-01 clinical trial are highly encouraging... We are expanding trial enrollment to expose more patients to the potential benefit of Deltacel while bolstering our clinical dataset."
Dr. Afshin Eli Gabayan, Medical Oncologist, Medical Director, and Principal Investigator at BHCC, commented, "The remarkable 33% tumor reduction seen in the first and fourth patient at our center along with the encouraging 9.5% reduction in the seventh patient, are truly exciting results from the Deltacel-01 clinical trial... These data, coupled with the patients' reports of improved energy and better quality of life, reinforce the potential of Kiromic's gamma delta T-cell therapy to deliver meaningful clinical benefit for patients with advanced lung cancer who have exhausted other treatment options."
Deltacel-01 Trial Design
The Deltacel-01 trial (NCT06069570) is an open-label Phase 1 study evaluating the safety and tolerability of gamma delta T cell infusions in combination with low-dose radiotherapy in subjects with stage 4 metastatic NSCLC. Patients receive three intravenous infusions of Deltacel™ along with six courses of low-dose, localized radiation over a 31-day period. The trial's primary objective is to assess safety, with secondary endpoints including objective response, progression-free survival, overall survival, time to progression, time to treatment response, and disease control rates.
About Deltacel
Deltacel™ (KB-GDT-01) is an investigational allogeneic gamma delta T-cell (GDT) therapy. It is designed to harness the natural potency of GDT cells to target solid tumors, with an initial clinical focus on NSCLC, which accounts for approximately 80% to 85% of all lung cancer cases. Preclinical data suggest a favorable safety and efficacy profile when Deltacel™ is combined with low-dose radiation.
Enrollment Update
Kiromic BioPharma has announced that the eighth patient has completed the Deltacel-01 treatment regimen and is tolerating the therapy well, with initial efficacy results expected in late February 2025. The ninth patient has started treatment at Virginia Oncology Associates, and the company anticipates enrolling the 10th and 11th patients by the end of January.
