A Phase 1 interventional study of NSC-CRAd-S-pk7 in Glioma, Malignant and New Diagnosis Tumor, sponsored by Northwestern University. Suspended at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Northwestern University · Phase 1, Interventional, and Treatment
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:
Participants will:
The treatment regimen contains 3 phases:
Surgical phase:
Patients undergo a biopsy and upon intraoperative confirmation of high grade glioma, NSC-CRAd-S-pk7 dose #1 will be injected into the biopsy site. Patients will undergo resection of the tumor 14 (+/- 3) days later, administration of second dose of the investigational product (NSC-CRAd-S-pk7 dose #2), and implantation of the catheter system. The investigational product will then be given monthly for a total of 6 doses (see below).
Radiotherapy phase:
After recovery from surgery (usually within 2 weeks), standard chemoradiotherapy will be initiated consisting of daily radiotherapy (2 Gy per fraction x 30 fractions) and concomitant temozolomide (TMZ) chemotherapy (75 mg/m2 daily from day 1 of RT until last day of RT).
About 10-14 days into radiotherapy (= approx. 4 weeks after intraoperative dose #2), patients will be receiving NSC-CRAd-S-pk7 dose #3 through the previously implanted catheter system. This also marks the beginning of the formal dose-limiting toxicity (DLT) period, as this virus' survivin gene promoter is activated by the concomitant irradiation.
Four weeks later, ie. at the end of radiotherapy dose #4 is administered as previously, provided no DLT toxicity has been observed and viral treatment related toxicities have returned to grade ≤ 2.
Adjuvant (also called maintenance) phase:
As per standard of care, approx. 4 weeks after end of radiotherapy, patients will start maintenance TMZ chemotherapy (150 - 200 mg/m2, daily x 5 every 28 days) and loco-regional treatment with alternating Tumor Treating Fields (TTFields, Optune®). NSC-CRAd-S-pk7 doses #5 and #6 will be administered concurrently (± 3 days) with adjuvant cycle 1 and 2 of TMZ.
1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.
This study's planned enrollment of 20 is below the median of 32 across 1,065 interventional studies indexed under Glioma.
Browse Glioma studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Dose-limiting toxicity of repeat NSC-CRAd-S-pk7 dosing
Determination of the dose limiting toxicity of repeated dosing of NSC-CRAd-S-pk7
Time frame: 8 weeks
Objective response to therapy
Objective response to therapy as determined by Immune Response Assessment in Neuro-Oncology (iRANO) criteria
Time frame: 5 years
Overall survival
Overall survival time from the first study product injection to death
Time frame: 5 years
Progression-free survival
Time from the first study product injection to first confirmed disease progression as determined by objective tumor response
Time frame: 18 months
Functional Assessment of Cancer Therapy-Brain (FACT-Br) score change
Change in score on FACT-Br over time as a measure of quality of life, with scores ranging from 0-200; higher scores indicate better quality of life.
Time frame: 22 weeks
Plan to share: No — No individual participant data (IPD) will be shared with other researchers.
This study is suspended, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Northwestern University