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.
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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 a
SUBMITTER: Qian X
PROVIDER: S-EPMC12304309 | biostudies-literature | 2025 Jul
REPOSITORIES: biostudies-literature
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