20.500.12556/RUL-166725 Phase I trial of phIL12 plasmid intratumoral gene electrotransfer in patients with basal cell carcinoma in head and neck region Introduction: In the treatment of cancer, immunomodulatory approaches are developed to support the organism in fighting cancer or to enhance the immunomodulatory effects of local ablative techniques. To this end, we conducted an interventional, open-label, single-arm Phase I trial to evaluate the safety and tolerability of intratumoral phIL12 plasmid DNA gene electrotransfer as primary objectives. Methods: The study was dose-escalating with 3 consecutive cohorts of 3 patients per phIL12 dose level (0.5 mg/ml, 1 mg/ml or 2 mg/ml) according to a matched 3 + 3 design. Recruitment of patients was staggered. The waiting period was 30 days after treatment of the previous patient, based on the expected duration of acute and subacute toxicity. Results: The results of this phase I clinical trial in basal cell carcinoma demonstrated the feasibility and safety of the phIL12 plasmid by gene electrotransfer. We were able to demonstrate that phIL12 gene electrotransfer induced local IL-12 production, which was accompanied with IFN-γ expression. Triggering of the immune response was demonstrated by increased infiltration of immune cells and some antitumor effect. Based on these data, we would recommend the use of a concentration of 2 mg/ml of the plasmid in future trials. Conclusion: The trial lays the foundation for future Phase II clinical trials in which phIL12 gene electrotransfer is used in combination with local tumor-ablative approaches, such as electrochemotherapy or radiotherapy. phase I clinical trial phIL12 plasmid interleukin-12 gene electrotransfer basal cell carcinoma onkologija karcinom glava vrat true false true Angleški jezik Slovenski jezik Članek v reviji 2025-01-23 09:00:53 2025-01-23 09:00:54 2025-01-24 04:05:29 0000-00-00 00:00:00 2025 0 0 10 str. iss. 5, art. 109574 Vol. 51 May 2025 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 616-006 1532-2157 10.1016/j.ejso.2025.109574 223496195 1-s2.0-S0748798325000022-main.pdf 1-s2.0-S0748798325000022-main.pdf 1 E5222E5420E3517C41290BF85F734802 cc872b2b7af00bfbbba0cf355ae3e8def67bce9a6801fe23c4fe07aac7d1d148 9e5c154d-d95f-11ef-b232-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=198544 https://www.sciencedirect.com/science/article/pii/S0748798325000022 0 9089209d-d95f-11ef-b232-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=198543 https://www.ejso.com/article/S0748-7983(25)00002-2/fulltext 1 612466b1-d95f-11ef-b232-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=198542 Medicinska fakulteta Zdravstvena fakulteta Veterinarska fakulteta Biotehniška fakulteta 0 0 0