The oncolytic adenovirus Ad-TD-nsIL12 in primary or progressive pediatric IDH wild-type diffuse intrinsic pontine glioma results of two phase I clinical trials

Xiao Qian, Weihai Ning, Jingjing Yang, Louisa Chard Dunmall, Hardev S. Pandha, Guanjie Shang, Yuduo Guo, Dongxu Zhang, Yanming Qu, Haoran Wang, Chunyu Gu, Mingshan Zhang, Yaohe Wang, Shengdian Wang and Hongwei Zhang ()
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Xiao Qian: Capital Medical University
Weihai Ning: Capital Medical University
Jingjing Yang: Capital Medical University
Louisa Chard Dunmall: Queen Mary University of London
Hardev S. Pandha: University of Surrey
Guanjie Shang: Capital Medical University
Yuduo Guo: Capital Medical University
Dongxu Zhang: Capital Medical University
Yanming Qu: Capital Medical University
Haoran Wang: Capital Medical University
Chunyu Gu: Capital Medical University
Mingshan Zhang: Capital Medical University
Yaohe Wang: Queen Mary University of London
Shengdian Wang: Chinese Academy of Sciences
Hongwei Zhang: Capital Medical University

Nature Communications, 2025, vol. 16, issue 1, 1-12

Abstract: Abstract Two single-center Phase I trials evaluated safety (primary endpoint) and preliminary efficacy (secondary endpoint) of oncolytic adenovirus Ad-TD-nsIL12 in primary (Group A, NCT05717712) and progressive (Group B, NCT05717699) pediatric patients with IDH wild-type (WT) diffuse intrinsic pontine glioma (DIPG). Studies employed single-arm and 3 + 3 dose-escalation design. 9 patients were enrolled in Group A and 6 in Group B. Group A completed the dose escalation, and no severe adverse events were observed. Enrollment in Group B was halted after Group A completed escalation. All patients experienced drug-related adverse events. In Group A, three partial responses and five stable diseases were documented, with a median overall survival (mOS) of 10.3 months after the first virus and 11.3 months after onset. In Group B, three patients had stable diseases, and three had progressive disease, with an mOS of 6.4 months after the first virus and 12.7 months after onset. Both groups demonstrated improved mOS from onset compared to the DIPG patients in our center’s retrospective study (mOS, 8.3 months). Both groups showed increased lymphocytes post-treatment, but only Group A decreased after radiotherapy. These trials confirmed the safety of Ad-TD-nsIL12 and provided preliminary efficacy evidence, offering insights for future clinical applications in DIPG.

Date: 2025
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DOI: 10.1038/s41467-025-62260-5

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