Treatment of skin tumors with intratumoral interleukin 12 gene electrotransfer in the head and neck region: a first-in-human clinical trial protocol.
basal cell carcinoma
gene electrotransfer
gene therapy
head and neck region
interleukin 12
Journal
Radiology and oncology
ISSN: 1581-3207
Titre abrégé: Radiol Oncol
Pays: Poland
ID NLM: 9317213
Informations de publication
Date de publication:
14 08 2022
14 08 2022
Historique:
received:
01
04
2022
accepted:
07
04
2022
pubmed:
11
5
2022
medline:
17
8
2022
entrez:
10
5
2022
Statut:
epublish
Résumé
Immune therapies are currently under intensive investigation providing in many cases excellent responses in different tumors. Other possible approach for immunotherapy is a targeted intratumoral delivery of interleukin 12 (IL-12), a cytokine with anti-tumor effectiveness. Due to its immunomodulatory action, it can be used as an imunostimulating component to in situ vaccinating effect of local ablative therapies. We have developed a phIL12 plasmid devoid of antibiotic resistance marker with a transgene for human IL-12 p70 protein. The plasmid can be delivered intratumorally by gene electrotransfer (GET). Here we present a first-in-human clinical trial protocol for phIL12 GET (ISRCTN15479959, ClinicalTrials NCT05077033). The study is aimed at evaluating the safety and tolerability of phIL12 GET in treatment of basal cell carcinomas in patients with operable tumors in the head and neck region. The study is designed as an exploratory, dose escalating study with the aim to determine the safety and tolerability of the treatment and to identify the dose of plasmid phIL12 that is safe and elicits its biological activity. The results of this trail protocol will therefore provide the basis for the use of phIL12 GET as an adjuvant treatment to local ablative therapies, to potentially increase their local and elicit a systemic response.
Sections du résumé
BACKGROUND
Immune therapies are currently under intensive investigation providing in many cases excellent responses in different tumors. Other possible approach for immunotherapy is a targeted intratumoral delivery of interleukin 12 (IL-12), a cytokine with anti-tumor effectiveness. Due to its immunomodulatory action, it can be used as an imunostimulating component to in situ vaccinating effect of local ablative therapies. We have developed a phIL12 plasmid devoid of antibiotic resistance marker with a transgene for human IL-12 p70 protein. The plasmid can be delivered intratumorally by gene electrotransfer (GET).
PATIENTS AND METHODS
Here we present a first-in-human clinical trial protocol for phIL12 GET (ISRCTN15479959, ClinicalTrials NCT05077033). The study is aimed at evaluating the safety and tolerability of phIL12 GET in treatment of basal cell carcinomas in patients with operable tumors in the head and neck region. The study is designed as an exploratory, dose escalating study with the aim to determine the safety and tolerability of the treatment and to identify the dose of plasmid phIL12 that is safe and elicits its biological activity.
CONCLUSIONS
The results of this trail protocol will therefore provide the basis for the use of phIL12 GET as an adjuvant treatment to local ablative therapies, to potentially increase their local and elicit a systemic response.
Identifiants
pubmed: 35535423
pii: raon-2022-0021
doi: 10.2478/raon-2022-0021
pmc: PMC9400442
doi:
Substances chimiques
Interleukin-12
187348-17-0
Banques de données
ISRCTN
['ISRCTN15479959']
ClinicalTrials.gov
['NCT05077033']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
398-408Informations de copyright
© 2022 Ales Groselj, Masa Bosnjak, Tanja Jesenko, Maja Cemazar, Bostjan Markelc, Primoz Strojan, Gregor Sersa, published by Sciendo.
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