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NOT YET RECRUITING
NCT07902037
PHASE1/PHASE2

A Study of SRN-101 Gene Therapy in Adults With Recurrent High-Grade Glioma (ALERT-1)

Sponsor: Siren Biotechnology

View on ClinicalTrials.gov

Summary

ALERT-1 is a Phase 1/2 study evaluating the safety and preliminary anti-tumor activity of SRN-101, an investigational gene therapy, in adults with recurrent high-grade glioma. High-grade glioma is a type of brain cancer. This study is for adults whose cancer has returned for the first time and for whom surgical removal of the tumor is not planned. SRN-101 uses an adeno-associated virus (AAV) to deliver a gene for human interferon beta, a protein within the tumor. The safety and effectiveness of SRN-101 in this setting have not been established. Each participant will receive one infusion of SRN-101 directly into the brain tumor during an MRI-guided procedure. The study will first evaluate different dose levels and then evaluate a selected dose in additional participants. Participants will have MRI scans, blood tests and other health assessments, and follow-up visits to assess safety and changes in their cancer.

Official title: A Phase 1/2, Dose-Escalation and Expansion Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of SRN-101, a Recombinant Adeno-Associated Virus Immunotherapy in Adults With Recurrent High-Grade Glioma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-12

Completion Date

2030-01

Last Updated

2026-10-28

Healthy Volunteers

No

Interventions

GENETIC

SRN-101

SRN-101 is an investigational AAV-based gene therapy encoding human interferon beta (hIFNβ). SRN-101 is administered as a single intratumoral infusion using MRI-guided CED.