Actively Recruiting
MSC-DNX-2401 in Treating Patients With Recurrent High-Grade Glioma
Led by M.D. Anderson Cancer Center · Updated on 2026-03-05
36
Participants Needed
1
Research Sites
450 weeks
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
This phase I trial studies best dose and side effects of oncolytic adenovirus DNX-2401 in treating patients with high-grade glioma that has come back (recurrent). Oncolytic adenovirus DNX-2401 is made from the common cold virus that has been changed in the laboratory to make it less likely to cause an infection (such as a cold). The virus is also changed to target brain cancer cells and attack them.
CONDITIONS
Official Title
MSC-DNX-2401 in Treating Patients With Recurrent High-Grade Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to give informed consent and follow study procedures
- Diagnosed with recurrent malignant glioblastoma, gliosarcoma, or anaplastic astrocytoma with wild-type IDH-1, or IDH-mutant grade 4 astrocytoma at recurrence
- Tumor size between 1.0 cm and 5 cm in diameter on MRI
- Evidence of tumor recurrence or progression after prior treatments
- Age 18 years or older
- Able to undergo endovascular treatment with less than 50% occlusion in the internal carotid artery
- Tumors must be surgically resectable for patients undergoing tumor removal
- Karnofsky performance score of 70 or higher
- Life expectancy of at least 16 weeks
- Adequate bone marrow, liver, and kidney function
- Prothrombin time or partial thromboplastin time within 1.5 times the upper limit of normal
- Completed prior chemotherapy or targeted therapies within specified timeframes and recovered from side effects
- Willingness to use effective birth control during the study and for 6 months after treatment
- Women of childbearing potential must have a negative pregnancy test at screening
You will not qualify if you...
- Histology other than glioblastoma, gliosarcoma, IDH wild-type grade III astrocytoma, or IDH-mutant grade 4 astrocytoma
- Tumors located below the tentorium, in the posterior fossa, or with leptomeningeal spread
- Difficulty obtaining vascular access or ipsilateral carotid stenosis greater than 50%
- Blood clotting disorders or recent transfusions or medications affecting blood counts
- Recent biologic or immunotherapy within 2 weeks before treatment
- Inflammatory or autoimmune disorders
- Contraindications to MRI such as pacemakers or metal implants
- Pregnant or nursing women
- Active infection or unstable medical conditions
- Medical conditions preventing surgery or endovascular treatment
- Alcohol or substance abuse within 12 months causing health issues
- Immunocompromised status or active hepatitis or HIV
- Bleeding disorders or use of anticoagulants that cannot be stopped before surgery
- Psychiatric or medical conditions interfering with study participation
- Central nervous system infections or diseases like encephalitis or multiple sclerosis
- Known genetic syndromes like Li-Fraumeni or retinoblastoma gene defects
- Significant systemic illnesses like heart failure, stroke history, kidney failure, liver disease, or psychiatric disorders
- Participation in another therapeutic clinical trial
- Conditions preventing protocol compliance or therapy adherence
- For biological endpoint phase, inability to inject therapy safely after tumor resection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
F
Frederick Lang
CONTACT
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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