Using neural stem cells with a virus to treat recurrent high-grade brain tumors
Official title: A Phase I Study of Multiple Doses of Neural Stem Cell-Based Oncolytic Virotherapy (NSC-CRAd-S-pk7) Administered Intracerebrally to Patients With Recurrent High-Grade Gliomas
Run by City of Hope Medical Center · NCT05139056 · Data updated 2026-11-12
This study is testing a new treatment using neural stem cells and a virus to see if it can help people with recurrent high-grade brain tumors feel better and live longer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | bevacizumab, chemotherapy, radiation |
| Locations | 4 sites (Duarte, California and 3 other locations) |
| Status | Recruiting |
| Started | May 2, 2023 |
| Main results expected | February 7, 2028 |
| Study ends | February 7, 2028 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT05139056 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with recurrent high-grade gliomas who require surgical intervention and have a Karnofsky performance status of 70% or higher.
✕Probably not a fit
Patients with low-grade gliomas or those who have not experienced recurrence after initial treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase I trial investigates the effects of multiple doses of NSC-CRAd-S-pk7, a treatment involving neural stem cells that carry a virus designed to kill cancer cells, in patients with recurrent high-grade gliomas. The primary objective is to determine the maximum tolerated number of treatment cycles based on dose-limiting toxicities and overall toxicity profile. Secondary objectives include measuring immune responses, evaluating the distribution of the treatment in the brain, and assessing disease response rates and survival outcomes. The study aims to provide insights into the safety and efficacy of this innovative approach for treating aggressive brain tumors.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with recurrent high-grade gliomas, potentially improving survival rates and quality of life.
How similar studies have gone: While the use of oncolytic viruses in cancer treatment is an emerging field, this specific approach using neural stem cells is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient must be age \>= 18 years * Patient has a Karnofsky performance status of \>= 70% * Patient has a life expectancy of \>= 3 months * When determining the maximum tolerated number of treatment cycles (MTC): patient has a histologically confirmed diagnosis of a grade 3 or 4 glioma (eg., glioblastoma, grade 4 astrocytoma, grade 3 astrocytoma, grade 3 oligodendroglioma). (This part of the study has been completed). * When enrolling to Treatment Schedules 4 and 4a: patient has glioblastoma at first recurrence. * Imaging studies show evidence of recurrent, supratentorial tumor(s). * Patient's high-grade glioma has recurred or progressed after prior treatment with brain radiation and temozolomide * The patient must be in need of surgery for tumor resection * Based on the neurosurgeon's judgment, there is no anticipated physical connection between the post-resection tumor cavity and the cerebral ventricles * Absolute neutrophil count (ANC) of \>= 1000 cells/mm\^3 * Platelet count \>= 100,000 cells/mm\^3 * Total bilirubin =\< 2.0 mg/dl * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 4 times the institutional upper limit of normal * Serum creatinine =\< the institutional upper limit of normal * At least 2 weeks from taking the last dose of a targeted agent * At least 4 weeks from the last dose of bevacizumab For temozolomide, an interval of 23 days is required from the last dose administered if the patient was recently treated with adjuvant temozolomide, consisting of temozolomide daily for 5 days, repeated every 28 days. * At least 2 weeks from taking the last dose of a targeted agent. * At least 4 weeks from the last dose of bevacizumab. * All significant toxicities from previous anticancer therapy must have stabilized to a new baseline or resolved. * All participants must have the ability to understand and the willingness to sign a written informed consent. * The effects of this treatment on a developing fetus are unknown. Therefore, female patients of childbearing potential and sexually-active male patients or who are able to impregnate their partner, must agree to use an effective method of contraception while participating in this study. Patients of childbearing potential must have a negative pregnancy test =\< 2 week prior to registration. Exclusion Criteria: * Patient has multi-focal disease. * Patient is receiving radiation, chemotherapy, or another investigational agent. * Patient has had prior therapy with neural stem cells. * Patient has not recovered from any toxicity (\> grade 1) of prior therapies, except alopecia. * Patient is unable to undergo a brain MRI. * Patient has chronic or active viral infections of the central nervous system (CNS). * Patient has a coagulopathy or bleeding disorder. * Patient has an uncontrolled illness including ongoing or active infection. * Patient has another active malignancy. * Patient is pregnant or breastfeeding. * A patient has a serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the safety monitoring requirements and completion of treatment according to this protocol.
Where it's running
-
City of Hope Medical Center
Duarte, California, United States Recruiting -
Standford University
Stanford, California, United States Recruiting -
Northwestern University
Chicago, Illinois, United States Suspended -
Wake Forest University
Winston-Salem, North Carolina, United States Not yet recruiting
Study contacts
- Principal investigator: Jana L Portnow, MD — City of Hope Medical Center
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.