NCT06169280 Repeated Neural Stem Cell Based Virotherapy for Newly Diagnosed High Grade Glioma
| NCT ID | NCT06169280 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Northwestern University |
| Condition | Glioma, Malignant |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-06-27 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2025-06-27 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 (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 Criteria
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.
Contact & Investigator
Roger Stupp, MD
PRINCIPAL INVESTIGATOR
Northwestern University
Frequently Asked Questions
Who can join the NCT06169280 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioma, Malignant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06169280 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06169280 currently recruiting?
Yes, NCT06169280 is actively recruiting participants. Contact the research team at braintumortrials@nm.org for enrollment information.
Where is the NCT06169280 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06169280 clinical trial?
NCT06169280 is sponsored by Northwestern University. The principal investigator is Roger Stupp, MD at Northwestern University. The trial plans to enroll 20 participants.