Perfusion-guided endovascular super-selective intra-arterial infusion for treatment of malignant brain tumors.
Stephen R Chen, Melissa M Chen, Chibawanye Ene...
https://pubmed.ncbi.nlm.nih.gov/34824133Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID03896568
Phase I Clinical Trial of Bone Marrow Stem Cells Loaded With Oncolytic Adenovirus DNX-2401 Delivered by Intra-Arterial Injection in Patients With Recurrent High-Grade Glioma
Led by M.D. Anderson Cancer Center · Updated on 2026-03-05
36
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
D
DNAtrix, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the use of oncolytic adenovirus DNX-2401 carried by allogeneic bone marrow-derived human mesenchymal stem cells (BM-hMSCs) to treat patients with recurrent high-grade gliomas, including glioblastoma, gliosarcoma, and certain types of astrocytomas. This phase I trial aims to find the best dose and understand side effects of this treatment delivered directly into the brain arteries. The virus is modified from the common cold virus to target and attack brain cancer cells while being less likely to cause infection. The study has two parts: In Part I, patients receive one or two intra-arterial infusions of BM-hMSCs-DNX2401 over 20 to 30 minutes on day 0. Dose levels 1 to 5 receive one infusion, while dose level 6 receives two infusions. In Part II, patients receive the highest tolerated dose infusion(s) followed by surgery two weeks later to remove the tumor, then an injection of BM-hMSCs-DNX2401 directly into the tumor cavity. Patients are then followed closely with regular visits and assessments over months to monitor their condition. Participants undergo brain tumor imaging, blood and respiratory sample collection to monitor virus shedding and immune responses, and physical exams to assess side effects and tumor progression. Follow-up visits occur frequently during the first month, then at intervals of 6 to 8 weeks for up to two years or until the tumor returns. Researchers will measure the maximum tolerated dose, adverse events, tumor response, virus activity, immune response, and overall survival during the study period.
CONDITIONS
Brief Title
MSC-DNX-2401 in Treating Patients With Recurrent High-Grade Glioma
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older who can provide informed consent and follow all study procedures
- Diagnosis of recurrent malignant glioblastoma, gliosarcoma, or IDH-mutant or wild-type astrocytoma grade 4 with a tumor size between 1.0 and 5 cm
- Evidence of tumor recurrence or progression by MRI after prior treatments
- Ability to undergo endovascular treatment with less than 50% carotid artery blockage
- Karnofsky performance score of 70 or higher
- Life expectancy of at least 16 weeks
- Adequate bone marrow, liver, and kidney function
- Completion of certain chemotherapy treatments within specified timeframes before study entry
- Willingness to avoid other cancer treatments during the study
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control along with their partners
You will not qualify if you...
- Histology other than glioblastoma, gliosarcoma, or specified astrocytoma types
- Tumors located below the tentorium, within the posterior fossa, or with leptomeningeal spread
- Difficulty with vascular access or carotid artery stenosis over 50%
- Blood disorders or recent transfusions affecting blood counts
- Recent biologic or immunotherapy within 2 weeks
- Contraindications to MRI such as metal implants or pacemakers
- Pregnant or nursing women
- Active infections, unstable medical conditions, or immunocompromised status
- Use of anticoagulants that cannot be stopped before surgery
- Psychiatric or medical conditions interfering with participation or consent
- History of certain genetic syndromes
- Concurrent enrollment in other therapeutic clinical studies
- Conditions preventing protocol compliance or surgery as needed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 4 weeks
Participants receive one or two infusions of BM-hMSCs loaded with oncolytic adenovirus DNX-2401 by intra-arterial injection. In Part II, after 2 weeks, participants undergo surgery to remove the tumor followed by an intramural injection of BM-hMSCs-DNX-2401 into the resection cavity.
1 or 2 infusion visits and 1 surgery visit in Part II
Follow-up
Duration - Up to approximately 2 years or until tumor progression
After treatment, participants are monitored with scheduled visits to assess safety, tumor response, and survival until tumor progression.
Visits on days 1, 4, 7, and 14 of month 1; every 6 weeks for 6 months (4 visits); every 8 weeks for 1 year (6 visits); every 4 months for 1 year (3 visits); then every 6 months until tumor growth
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
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Research Team
F
Frederick Lang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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