Repeated Neural Stem Cell Based Virotherapy for Newly Diagnosed High Grade Glioma

NCT06169280 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: NU 23C02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma, Malignant; New Diagnosis Tumor

Keywords

Virotherapy; NSC-CRAd-S-pk7

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity of repeat NSC-CRAd-S-pk7 dosing

  Determination of the dose limiting toxicity of repeated dosing of NSC-CRAd-S-pk7

  8 weeks

Secondary Outcomes (3)

• Objective response to therapy

  5 years

• Overall survival

  5 years

• Progression-free survival

  18 months

Other Outcomes (1)

• Functional Assessment of Cancer Therapy-Brain (FACT-Br) score change

  22 weeks

Study Arms (1)

NSC-CRAd-S-pk7

EXPERIMENTAL

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.

Biological: NSC-CRAd-S-pk7

Interventions

NSC-CRAd-S-pk7 BIOLOGICAL

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.

NSC-CRAd-S-pk7

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years of age or older.
• Performance status (PS) must be WHO PS of \< 2.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (5)

• Ahmed AU, Thaci B, Tobias AL, Auffinger B, Zhang L, Cheng Y, Kim CK, Yunis C, Han Y, Alexiades NG, Fan X, Aboody KS, Lesniak MS. A preclinical evaluation of neural stem cell-based cell carrier for targeted antiglioma oncolytic virotherapy. J Natl Cancer Inst. 2013 Jul 3;105(13):968-77. doi: 10.1093/jnci/djt141.

  PMID: 23821758 BACKGROUND

• Ahmed AU, Thaci B, Alexiades NG, Han Y, Qian S, Liu F, Balyasnikova IV, Ulasov IY, Aboody KS, Lesniak MS. Neural stem cell-based cell carriers enhance therapeutic efficacy of an oncolytic adenovirus in an orthotopic mouse model of human glioblastoma. Mol Ther. 2011 Sep;19(9):1714-26. doi: 10.1038/mt.2011.100. Epub 2011 May 31.

  PMID: 21629227 BACKGROUND

• Fares J, Ahmed AU, Ulasov IV, Sonabend AM, Miska J, Lee-Chang C, Balyasnikova IV, Chandler JP, Portnow J, Tate MC, Kumthekar P, Lukas RV, Grimm SA, Adams AK, Hebert CD, Strong TV, Amidei C, Arrieta VA, Zannikou M, Horbinski C, Zhang H, Burdett KB, Curiel DT, Sachdev S, Aboody KS, Stupp R, Lesniak MS. Neural stem cell delivery of an oncolytic adenovirus in newly diagnosed malignant glioma: a first-in-human, phase 1, dose-escalation trial. Lancet Oncol. 2021 Aug;22(8):1103-1114. doi: 10.1016/S1470-2045(21)00245-X. Epub 2021 Jun 29.

  PMID: 34214495 BACKGROUND

• Kim CK, Ahmed AU, Auffinger B, Ulasov IV, Tobias AL, Moon KS, Lesniak MS. N-acetylcysteine amide augments the therapeutic effect of neural stem cell-based antiglioma oncolytic virotherapy. Mol Ther. 2013 Nov;21(11):2063-73. doi: 10.1038/mt.2013.179. Epub 2013 Jul 25.

  PMID: 23883863 BACKGROUND

• Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.

  PMID: 15758009 BACKGROUND

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Roger Stupp, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neurological Surgery

CONTACT

(312) 695-8143; braintumortrials@nm.org

Roger Stupp, MD

CONTACT

(312) 695-8143; roger.stupp@northwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study participants will receive up to 6 doses of NSC-CRAd-S-pk7 in addition to standard of care radiation and temozolomide.

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: June 27, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)