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

Trial ID: NCT06169280

Interventional - Phase 1 - Suspended

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.

Conditions

• Glioma, Malignant
• New Diagnosis Tumor

Interventions

• NSC-CRAd-S-pk7

Eligibility

Inclusion criteria

• 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.
• 18 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 criteria

• 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.

Sponsor

Northwestern University

Source: ClinicalTrials.gov

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