RecruitingPhase 1NCT06169280

Repeated Neural Stem Cell Based Virotherapy for Newly Diagnosed High Grade Glioma

A Phase I Study of Repeated Neural Stem Cell-Based Virotherapy and Standard Radiation and Chemotherapy for Newly Diagnosed High-Grade Glioma

Sponsor

Northwestern University

Enrollment

20 participants

Start Date

Jun 27, 2025

Study Type

INTERVENTIONAL

Conditions

Glioma, Malignant New Diagnosis Tumor

Summary

The goal of this clinical trial is to learn about the safety and feasibility of administering repeated doses of neural stem cell (NSC)-conditionally replicative adenovirus (CRAd)-survivin (S)-protomer (p)k7, in persons with newly diagnosed high grade glioma. The main questions it aims to answer are: * whether multiple doses of NSC-CRAd-S-pk7 are safe and feasible * how multiple doses of NSC-CRAd-S-pk7 influence tumor response, overall survival, time to tumor progression, and quality of life. Participants will: * undergo a biopsy to confirm high grade glioma, then receive the first dose of NSC-CRAd-S-pk7 into the brain * about 2 weeks later, undergo surgery to remove the tumor and receive the second dose of NSC-CRAd-S-pk7 into the brain * start chemoradiation about 2 weeks after surgery, then about 2 weeks later, receive the 3rd dose of NSC-CRAd-S-pk7 into the brain * four weeks later, at the end of chemoradiation, receive a fourth dose of NSC-CRAd-S-pk7 into the brain. * after radiation is finished, receive standard of care chemotherapy and tumor-treating fields. Two additional doses of NSC-CRAd-S-pk7 will be given every 4 weeks.

Eligibility

Min Age: 18 Years

Inclusion Criteria11

Diagnosis of a high-grade glioma (WHO grade 3 or grade 4).
Patients must have presumed high grade glioma (WHO grade 3 or 4) based on clinical and radiologic evaluation for registration.
A pathologic confirmation of high grade glioma must be made at the time of stereotactic biopsy prior to NSC-CRAd-S-pk7 injection; if this is not possible, the injection will not be performed and the subject will no longer be eligible for the study).
Tumor must be accessible for injection and must not be located in the brainstem or contained within the ventricular system.
Planning to undergo standard radiation/chemotherapy.
years of age or older.
Performance status (PS) must be WHO PS of < 2.
Stable or decreasing dose of corticosteroids equivalent to ≤ 6 mg/day for the 5 days prior to inclusion
Serum glutamic-oxaloacetic transaminase (SGOT or AST) < 3x upper limit of normal
Serum creatinine < 2mg/dl
Platelets > 100,000/mm3 and white blood cells (WBCs) > 3000/mm3

Exclusion Criteria7

Prior or ongoing liver disease including known cirrhosis.
Known hepatitis B or C infection, known HIV infection.
Chronic use of immunosuppressive drugs (with exception of corticosteroids required for mass effect).
Acute viral, bacterial or fungal infections requiring therapy.
Pregnant or breast-feeding patients.
Evidence of metastatic disease or other malignancy (except squamous or basal cell skin cancers).
Prior radiation therapy to the brain or prior treatment for brain tumor.

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Interventions

BIOLOGICALNSC-CRAd-S-pk7

NSC-CRAd-S-pk7 1·50 x 10⁸ NSCs loaded with1·875 x viral particles administered intra-tumorally on Day 0 and Day 15, then every 4 weeks for up to 6 total doses.