Neural Stem Cell Virotherapy for Cancer

Overseen By Neurological Surgery

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Northwestern University

Must not be taking: Immunosuppressive drugs

Disqualifiers: Liver disease, Hepatitis, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with high-grade glioma, an aggressive brain cancer. Researchers aim to determine if repeated doses of a special therapy, using neural stem cells (NSCs) with a virus targeting cancer cells, are safe and effective in controlling the tumor. Known as NSC-CRAd-S-pk7, this therapy uses neural stem cells to deliver a virus directly to cancer cells. The trial will monitor safety and assess the treatment's impact on tumor growth, survival rates, and quality of life. Individuals with this type of brain tumor who plan to undergo standard treatments like radiation and chemotherapy might be suitable candidates. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, it mentions that you should not be on chronic immunosuppressive drugs, except for certain corticosteroids. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that NSC-CRAd-S-pk7 is being tested for safety in treating brain tumors, specifically high-grade gliomas. In earlier studies, patients who received this treatment did not report a decrease in their quality of life. This was measured using a tool called FACT-Br, which allows patients to express their feelings about daily life and health.

Another study is examining the administration of multiple doses of this treatment directly into the brain for patients with glioblastoma, a type of brain cancer. This study is ongoing and primarily assesses the safety and feasibility of repeated doses.

As this is an early-phase trial, the main focus is on patient tolerance and treatment safety. Early-phase trials are generally cautious, first ensuring the treatment does not cause severe side effects. While information on long-term safety is limited, early results are promising and suggest that NSC-CRAd-S-pk7 could merit further study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard cancer treatments such as chemotherapy, radiation, or surgery, NSC-CRAd-S-pk7 employs a novel approach by using neural stem cells (NSCs) to deliver a cancer-fighting virus directly into tumors. This treatment is unique because it combines virotherapy with stem cell therapy, potentially enhancing the precision and effectiveness of targeting cancer cells while minimizing damage to healthy tissue. Researchers are excited about this treatment because it represents a new mechanism of action that could lead to more targeted and less harmful cancer therapies.

What evidence suggests that NSC-CRAd-S-pk7 might be an effective treatment for high grade glioma?

Research has shown that NSC-CRAd-S-pk7, a treatment using specialized brain cells to deliver a virus, may help combat high-grade gliomas, a serious type of brain cancer. In earlier studies, this method shrank tumors and possibly improved survival rates. The treatment targets cancer cells directly while sparing healthy tissue. Initial findings suggest that using these brain cells enhances treatment effectiveness and reduces side effects. Although still in the early stages, this research offers hope for a better treatment option for brain tumors. ^{3 4 5 6 7}

Who Is on the Research Team?

Roger Stupp, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for individuals with newly diagnosed high-grade glioma (WHO grade 3 or 4), confirmed by biopsy. They must have a tumor that can be injected, not in the brainstem or ventricles, and a good performance status (WHO PS < 2). Their kidney function should be normal (creatinine < 2mg/dl) and liver enzymes within acceptable limits. Participants need to plan for standard radiation/chemotherapy and manage on low-dose corticosteroids.

Inclusion Criteria

Your blood creatinine level is less than 2mg/dl.

My brain tumor is likely high grade based on tests and scans.

My tumor can be reached for treatment and is not in my brainstem or ventricles.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical

Biopsy and intraoperative confirmation of high-grade glioma, followed by the first dose of NSC-CRAd-S-pk7 and tumor resection

2 weeks

In-person surgical visits

Radiotherapy

Standard chemoradiotherapy with daily radiotherapy and concomitant temozolomide, along with NSC-CRAd-S-pk7 doses

6 weeks

Daily radiotherapy sessions

Adjuvant

Maintenance TMZ chemotherapy and Tumor Treating Fields, with additional NSC-CRAd-S-pk7 doses

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

22 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NSC-CRAd-S-pk7

Trial Overview The trial tests repeated doses of NSC-CRAd-S-pk7 virotherapy delivered directly into the brain of glioma patients. It examines safety, feasibility, tumor response, survival rates, progression time, and quality of life impacts. Patients will receive multiple treatments before and after surgery plus chemoradiation; half will also get N-acetylcysteine amide until surgery.

How Is the Trial Designed?

Group I: NSC-CRAd-S-pk7 Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8328944/

Neural Stem Cell Delivery of an Oncolytic Adenovirus in ... Malignant glioma is the most common and lethal primary brain tumor, with dismal survival rates and no effective treatment.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05139056

NCT05139056 | Multiple Intracerebral Doses of Neural ... This phase I trial studies the safety of giving multiple intracerebral doses of NSC-CRAd-S-pk7 to treat patients with glioblastoma at first recurrence.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6350263/

Enhanced Delivery of Oncolytic Adenovirus by Neural ... Collectively, our data suggest NSC-delivered CRAd-S-pk7 virotherapy holds promise for improving clinical outcome, reducing toxicities, and improving quality of ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.TPS2102

Phase 1 study of multiple intracerebral doses of a neural ... A first-in-human clinical trial (NCT03072134) in newly diagnosed high grade glioma patients showed safety of a single intracerebral dose of NSC- ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03072134

NCT03072134 | Neural Stem Cell Based Virotherapy of ... Malignant gliomas have a very poor prognosis with median survival measured in months rather than years. It is a disease in great need of novel therapeutic ...

6. clinicaltrials.stanford.edu clinicaltrials.stanford.edu/trials/m/NCT05139056.html

Multiple Intracerebral Doses of Neural Stem Cell-Based ... This phase I trial studies the safety of giving multiple intracerebral doses of NSC-CRAd-S-pk7 to treat patients with glioblastoma at first recurrence.

7. cancer.gov cancer.gov/clinicaltrials/NCI-2023-06242

Repeated Neural Stem Cell Based Virotherapy with or ... Giving NSC-CRAd-S-pk7 with or without NACA and standard radiation with TMZ may kill more tumor cells in patients with newly diagnosed high grade glioma.