Kiromic BioPharma announced positive preliminary results from its Deltacel-01 Phase 1 clinical trial, evaluating Deltacel™ (KB-GDT-01) in patients with stage 4 metastatic non-small cell lung cancer (NSCLC). The data, reported on December 12, 2024, highlight the potential of this allogeneic gamma delta T-cell (GDT) therapy for patients who have failed to respond to standard treatments. The open-label trial aims to evaluate the safety and tolerability of Deltacel in combination with low-dose radiotherapy.
Tumor Reduction and Disease Stabilization
In the trial, the fourth patient experienced an approximately 32% decrease in tumor volume eight months post-treatment, showing a partial response without any reported adverse events. Furthermore, the first patient enrolled in the Deltacel-01 trial maintained stable disease for 11 months, with an initial tumor size reduction of approximately 27% compared to pre-treatment levels. No new sites of malignancy were identified in this patient.
Deltacel-01 Trial Details
The ongoing Phase 1 trial (NCT06069570) involves patients with stage 4 NSCLC receiving two intravenous infusions of Deltacel™ along with four courses of low-dose, localized radiation over a 10-day period. The primary objective is to assess safety, while secondary endpoints include objective response rate, progression-free survival (PFS), overall survival (OS), time to progression (TTP), time to treatment response (TTR), and disease control rate (DCR).
Expanding Patient Enrollment
The seventh patient has completed the Deltacel-01 treatment regimen and is tolerating the therapy well, with initial efficacy results expected in early January 2025. The eighth patient was recently enrolled at the Clinical Research Advisors Koreatown, a satellite location of the Beverly Hills Cancer Center (BHCC).
Expert Commentary
Pietro Bersani, Chief Executive Officer of Kiromic BioPharma, stated, "The magnitude of the tumor reduction observed in Patient #4 is significant and highly encouraging. We look forward to reporting results from the first and seventh patients in January and expect to enroll additional patients through the beginning of 2025."
Dr. Afshin Eli Gabayan, Medical Oncologist, Medical Director, and Principal Investigator at Beverly Hills Cancer Center, added, "The remarkable 32% tumor reduction seen in the fourth patient treated with Deltacel is truly exciting and holds great promise for improving outcomes for patients with advanced lung cancer... The early safety and tolerability data, coupled with these signs of robust antitumor activity, suggest Deltacel’s promise as a transformative new treatment option."
About Deltacel
Deltacel™ (KB-GDT-01) is an investigational allogeneic gamma delta T-cell therapy. It is designed to harness the natural ability of GDT cells to target solid tumors, with an initial clinical focus on NSCLC, which accounts for approximately 80-85% of all lung cancer cases. Preclinical data have indicated a favorable safety and efficacy profile when Deltacel™ is combined with low-dose radiation.
