NCT07902037Not yet recruitingPhase 1/2
A Study of SRN-101 Gene Therapy in Adults With Recurrent High-Grade Glioma (ALERT-1)
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
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 14 Oct 2026
- Start date
- Dec 2026
- Primary completion date
- Jan 2030
- Lead sponsor
- Siren Biotechnology
- Diseases
- Glioblastoma
- NCT number
- NCT07902037
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 40
- From Dec 2026 to the primary completion date, Jan 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving another tumor immunotherapy
- Recent initiation or increase in systemic immunosuppressive therapy, including corticosteroids, except as permitted by the protocol
Other illness
- Disseminated or multifocal disease
- History of or current liver disease, including active hepatitis B or hepatitis C, or human immunodeficiency virus
- Other medical conditions that, in the Investigator's judgment, could negatively affect the participant's ability to benefit from or tolerate the study
Other
- Pregnant or breastfeeding
- Recent neurologic dysfunction or abnormality that, in the Investigator's judgment, would prevent participation
- Unable to comply with the study's safety monitoring requirements
- Unable to undergo magnetic resonance imaging (MRI)
Who the study is looking for
- First recurrence of high-grade glioma for which surgical resection is not planned
- Eligible tumor type, including Grade 3 or Grade 4 astrocytoma, Grade 3 oligodendroglioma, glioblastoma, or diffuse hemispheric glioma, with histologic confirmation of malignancy
- Received prior standard treatment for high-grade glioma, including surgery followed by radiation alone or radiation with temozolomide
- A single tumor located above the tentorium that is accessible for treatment with SRN-101 and is 1 to 4 centimeters in diameter
- Karnofsky performance status of at least 70%
- Life expectancy of at least 3 months
- Recovered from the acute effects of prior anti-cancer treatment and meets required waiting periods following prior chemotherapy, radiation therapy, and major surgery
- Adequate bone marrow, kidney, liver, and blood-clotting function
- Willing to participate in the long-term safety follow-up study
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.