Status:
RECRUITING
Repeated Neural Stem Cell Based Virotherapy for Newly Diagnosed High Grade Glioma
Lead Sponsor:
Northwestern University
Conditions:
Glioma, Malignant
New Diagnosis Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Detailed Description
The treatment regimen contains 3 phases: Surgical phase: Patients undergo a biopsy and upon intraoperative confirmation of high grade glioma, NSC-CRAd-S-pk7 dose #1 will be injected into the biopsy ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06169280
Start Date
June 27 2025
End Date
December 31 2030
Last Update
October 6 2025
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611