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MSC-DNX-2401 for Recurrent High-Grade Glioma

This study is testing a treatment called oncolytic adenovirus DNX-2401, which is a modified common cold virus designed to target and attack brain cancer cells. It's being delivered using mesenchymal stem cells (MSC) and given directly into an artery. The trial is for patients aged 18 and older with high-grade glioma (a type of brain cancer) that has returned, specifically recurrent glioblastoma, gliosarcoma, or anaplastic astrocytoma. The main goals are to find the highest safe dose of MSC-DNX-2401 and to understand its side effects. Researchers will also look at how well the treatment reaches the tumor. This is a Phase 1 study, meaning it's an early-stage trial to assess safety and dosage.

Study design
This is an interventional study with a planned enrollment of 36 participants. It is a Phase 1 trial, focusing on finding the maximum tolerated dose.
What's involved
Participants will undergo surgery and receive the oncolytic adenovirus DNX-2401 via intra-arterial injection. They will need to comply with all study assessments and adhere to the protocol schedule.
Compensation
Not stated in the trial record.
Follow-up
Adverse events will be monitored for up to 1 year after treatment.

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NCT03896568

MSC-DNX-2401 in Treating Patients With Recurrent High-Grade Glioma

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~36 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:Oncolytic Adenovirus Ad5-DNX-2401Therapeutic Conventional Surgery

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum-tolerated dose (MTD)
Measured over Up to 28 days
+1 more outcome measured

Conditions

IDH1 wt Allele
Recurrent Anaplastic Astrocytoma
Recurrent Glioblastoma
Recurrent Gliosarcoma
Recurrent Malignant Glioma

Explore related trials

Anaplastic AstrocytomaGlioblastomaGliosarcoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Frederick F Lang · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Frederick Lang
[email protected]
713-792-2400
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Four weeks from cytotoxic agents (3 weeks from procarbazine or Temozolomide, 2 weeks from vincristine)
6 weeks from nitrosoureas (CCNU, BCNU)
Four weeks from any targeted investigational agent
One week from non-cytotoxic agents 13. This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender. 14. No exclusion to this study will be based on race. Minorities will actively be recruited to participate. The malignant glioma patient population treated at MDACC over the past year is as follows:
American Indian or Alaskan Native - 0
Asian or Pacific Islander - \<2%
Black, not of Hispanic Origin - 3%
Hispanic - 6%
White, not of Hispanic Origin - 88%
Other or Unknown - 2%
Total - 100% 15. Patients must be 8 weeks from radiotherapy to minimize the potential for MRI changes related to radiation necrosis that might be misdiagnosed as progression of disease, or 4 weeks if a new lesion, relative to the pre-radiation MRI, develops that is outside the primary radiation field (beyond 80% isodose line). However, if a biopsy is undertaken prior to these times and this biopsy documents histological evidence for recurrent disease, then patients will be eligible regardless of the time after radiation. 16. Patients must be willing to forego other cytotoxic and non-cytotoxic drug or radiation therapy against the tumor while enrolled in the study. 17. Women of childbearing potential must have a negative urine or serum pregnancy test at screening. 18. Subjects and their partners must be willing to use effective birth control during the study and for up to 6 months following administration of hMSC-DNX2401. Birth control that is acceptable to use in this study:
Using twice the normal protection of birth control (i.e., double-barrier) by using a condom AND spermicidal jelly or foam, or a diaphragm AND spermicidal jelly or foam. A spermicidal jelly or foam must be used in addition to a barrier method (e.g., condom or diaphragm)
Birth control pills ("The Pill")
Depot or injectable birth control
IUD (Intrauterine Device)
Birth Control Patch (e.g., Othro Evra®)
NuvaRing®
Surgical sterilization (i.e., tubal ligation or hysterectomy for women or vasectomy for men)

What this trial measures

  • Maximum-tolerated dose (MTD)Up to 28 days

    The MTD will be defined as the dose below the dose that results in greater than or equal to one-third of the subjects exposed who experienced grade 3 or 4 (except hematological, grade 4 required) toxicity according to National Cancer Institute Common Toxicity Criteria that is deemed to be at least "probably related" to the study drug (i.e., dose-limiting toxicity \[DLT\]).

  • Incidence of adverse events (AEs)Up to 1 year

    AEs will be summarized both overall and by dose group and tabulated by severity, relationship to BM-hMSCs-DNX 2401and causality. The number and percentage of subjects experiencing AEs will be tabulated by body system/preferred term both overall and by dose group. When an AE occurs more than once, the maximum severity and causality will be counted.