Recruiting

Phase 1

NSC-CRAd-S-pk7Multiple Intracerebral Doses of Neural Stem Cell-Based Virotherapy (NSC-CRAd-S-pk7) for the Treatment of Recurrent High-Grade Gliomas

Sponsor:

City of Hope Medical Center

Code:

NCT05139056

Conditions

Currently Only Enrolling Glioblastoma Patients at First Recurrence

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Neural Stem Cells-expressing CRAd-S-pk7

Resection

Study Details

Brief summary:

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. NSC-CRAd-S-pk7 consists of neural stem cells that can target glioblastoma cells and carry a virus, which can kill cancer cells. Giving multiple doses of NSC-CRAd-S-pk7 may kill more tumor cells.

Conditions

Currently Only Enrolling Glioblastoma Patients at First Recurrence

Study ID

NCT05139056

Start date

May 2, 2023

Status verified date

Sep, 2026

Completion date

Aug 4, 2027

Anticipated

Primary completion date

Aug 4, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

36 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (NSC-CRAd-S-pk7)

Patients undergo standard surgical resection, and during surgery the first dose of study agent is injected into the wall of the resection cavity. Patients then receive three additional doses every week or every two weeks (depending on when they enroll in the study) via a catheter that was placed during surgery

Interventions

Neural Stem Cells-expressing CRAd-S-pk7

Given intracerebrally

Resection

Undergo surgical resection

Primary outcome measure

Incidence of adverse events [ Time Frame: Up to 30 days post removal of Rickhams ]
Progression-free survival (PFS) [ Time Frame: From the time of surgery to the event date of progression, assessed at 6 months] ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Jana L. Portnow

626-218-9393 braintumortrials@coh.org

Principal Investigator:

Jana L. Portnow, MD

Standford University

Recruiting

Stanford, California, United States, 94305

Contacts

Melanie H Hayden Gephart, MD

650-497-7777 braintumorcenter@stanfordhealthcare.org

More Information

Sponsor

City of Hope Medical Center

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

Recurrent glioblastoma, oncolytic virus, neural stem cells, first recurrence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-09-09.