IDH1 wt AllelePhase 1NCT03896568
MSC-DNX-2401 in Treating Patients With Recurrent High-Grade Glioma
A Phase 1 study testing Oncolytic Adenovirus Ad5-DNX-2401 and Therapeutic Conventional Surgery in people with IDH1 wt Allele and Recurrent Anaplastic Astrocytoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IDH1 wt Allele, Recurrent Anaplastic Astrocytoma, Recurrent Glioblastoma
- What is being tested?
- Oncolytic Adenovirus Ad5-DNX-2401 and Therapeutic Conventional Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2019to 30 Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet the following inclusion criteria to be eligible and enroll:
- Subjects must be willing and able to provide informed consent, undergo and comply with all study assessments, and adhere to the protocol schedule.
- Patients with recurrent malignant GBM or gliosarcoma will be eligible. Patients with recurrent anaplastic astrocytoma with wild-type IDH-1 gene will also be eligible if there is a significant enhancing mass on MRI (≥1.0 cm in diameter with upper limit of 5 cm maximal diameter) because their prognosis/behavior is similar to GBM. Subjects with an initial diagnosis of an IDH-mutant grade 2 or 3 astrocytoma are also eligible at recurrence if a biopsy at recurrence is determined to be IDH-mutant grade 4 astrocytoma, and there is a significant enhancing mass on MRI (≥1.0 cm in diameter with upper limit of 5 cm maximal diameter). A pathology report constitutes adequate documentation of histology for study inclusion.
- Patients must show unequivocal evidence for tumor recurrence or progression by MRI scan after failing prior surgical resection, biopsy, chemotherapy or radiation. A baseline MRI must be performed within 24 days prior to registration. Biopsy is encouraged at the time of recurrence if it is unclear that there is recurrent tumor. However, biopsy is not required if the practicing physician thinks that there is adequate radiographic and clinical evidence for recurrence.
- Male or female patients ≥ 18 years of age.
- Patients must be able to undergo endovascular treatment based on Doppler studies showing ICA that is less than 50% occluded.
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- For patients undergoing resection for biological endpoints, tumors must be surgically resectable at the time of baseline evaluation and craniotomy for tumor resection is indicated as part of their standard medical care.
- Tumors must be ≥1.0 cm in diameter with upper limit of 5 cm maximal diameter.
- Patients must have a Karnofsky performance score ≥ 70.
- Patients must have a life expectancy of at least 16 weeks.
- Patients must have adequate bone marrow function (absolute granulocyte count > 1,500 and platelet count of > 75,000), adequate liver function (SGPT and SGOT and bilirubin < 2 times institutional normal ranges), and adequate renal function (creatinine < 2.0 times institutional normal) prior to starting therapy.
- Prothrombin time/international normalized ratio (PT/INR) or partial thromboplastin time (PTT) ≤ 1.5x ULN.
- Subjects who have received the following chemotherapies must have completed them within the following time periods prior to Baseline/Day 0 of hMSC-DNX2401 delivery with recovery from any drug-related toxic effects to Grade 1, or less, severity:
- 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
- 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.
- 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%
- 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.
- Patients must be willing to forego other cytotoxic and non-cytotoxic drug or radiation therapy against the tumor while enrolled in the study.
- Women of childbearing potential must have a negative urine or serum pregnancy test at screening.
- 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)
Who cannot join
- Histology other than GBM, gliosarcoma, IDH wild-type astrocytoma grade III or IDH-mutant astrocytoma grade 4.
- Tumor foci detected below the tentorium or beyond the cranial vault.
- Tumor within the posterior fossa.
- Tumor with leptomeningeal spread.
- Difficulty in obtaining vascular access for percutaneous procedure.
- Ipsilateral carotid stenosis (>50%, by Doppler studies).
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- Thrombophilias or primary hematological diseases.
- Transfusions or medications (G-CSF) to treat pancytopenia or other hematological conditions < 28 days prior to Baseline/Day 0/hMSC-DNX2401 administration.
- Biologic/immunotherapy within 2 weeks of baseline.
- Clinical or laboratory evidence of inflammatory and/or autoimmune disorders.
- Any contraindication for undergoing MRI such as: individuals with pacemakers, epicardial pacer wires, infusion pumps, surgical and/or aneurysm clips, shrapnel, metal prosthesis, implants with potential magnetic properties, metallic bodies in the eyes, etc. In addition, subjects must present with tumor that is evaluable by MRI.
- Pregnant or nursing females.
- Evidence of active uncontrolled infection or unstable or severe intercurrent medical conditions. All subjects must be afebrile (i.e., <38.0° Celsius [C]).
- Any medical condition that precludes surgery or endovascular treatment
- Alcoholism (dependency), alcohol or substance abuse within twelve (12) months prior to screening that has caused health consequences.
- Immunocompromised subjects or those with autoimmune conditions, active hepatitis (Liver function tests > 2x normal) or human immunodeficiency virus (HIV) seropositivity.
- Evidence of bleeding diathesis or use of anticoagulant medication or any medication that may increase the risk of bleeding that cannot be stopped prior to surgery. If the medication can be discontinued prior to DNX-2401 injection then the subject may be eligible following consultation with the Study Chair. Low weight heparin and Lovenox (enoxaparin) administered on a temporary limited basis for post procedure DVT prophylaxis is permitted.
- History or current diagnosis of any medical or psychological condition that in the Investigator's opinion might interfere with the subject's ability to participate or inability to obtain informed consent because of psychiatric or complicating medical problems.
- Encephalitis, multiple sclerosis or other central nervous system (CNS) infection or primary CNS disease that would interfere with subject evaluation.
- Subjects with known Li-Fraumini Syndrome or with a known germ line deficit in the retinoblastoma gene or its related pathways.
- Subjects with significant systemic or major illnesses including but not limited to: congestive heart failure, ischemic heart disease, cerebrovascular disease (history of strokes or TIAs in large vessel or small vessel distribution), kidney disease or renal failure, active liver disease, organ transplantation, or significant psychiatric disorder.
- Enrollment in a concomitant therapeutic clinical study.
- Any condition that prevents compliance with the protocol or adherence to therapy.
- For patients enrolled in the biological endpoint phase of the study, patients will be excluded if in the assessment of the surgeon, after resecting the tumor, there is high likelihood of injecting BM-hMSC-DNX2401 into the ventricles.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Frederick F. Lang, 713-792-2400
Frederick F. Lang
About this study
Official title: Phase I Clinical Trial of Allogeneic Bone Marrow Human Mesenchymal Stem Cells Loaded With A Tumor Selective Oncolytic Adenovirus, DNX-2401, Administered Via Intra-Arterial Injection in Patients With Recurrent High-Grade Glioma
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the maximal tolerated dose (MTD) of allogeneic bone marrow-derived human mesenchymal stem cells (BM-hMSCs) loaded with the oncolytic adenovirus DNX-2401 (BM-hMSCs-DNX2401) administered by intra-arterial injection (i.e., transfemoral endovascular intracranial injection) in patients with recurrent glioblastoma (GBM), IDH-mutant astrocytoma grade 4, gliosarcoma, or wild-type IDH-1 anaplastic astrocytoma.
II. To determine the local and systemic toxicity of allogeneic BM-hMSCs-DNX2401 administered by intra-arterial injection (i.e., transfemoral endovascular intracranial injection) in patients with recurrent GBM, gliosarcoma or wild-type IDH-1 anaplastic astrocytoma.
III. To determine at the molecular and cellular level the capacity of allogeneic BM-hMSCs-DNX2401 administered intra-arterially to home to and deliver DNX-2401 to recurrent GBM, gliosarcoma or wild-type IDH-1 anaplastic astrocytoma by analyzing post-treatment surgical brain tumor specimens for the expression and distribution of adenoviral proteins.
SECONDARY OBJECTIVES:
- To assess shedding of adenovirus into the blood, sputum, and nasopharynx after intra-arterial administration of BM-hMSCs-DNX2401 in patients with recurrent GBM, gliosarcoma or wild-type IDH-1 anaplastic astrocytoma.
II. To assess the development of anti-adenovirus antibodies after intra-arterial administration of BM-hMSCs-DNX2401 in patients with recurrent GBM, gliosarcoma or wild-type IDH-1 anaplastic astrocytoma.
III. To evaluate immune-mediated cytokine responses after intra-arterial administration of BM-hMSCs-DNX2401 in patients with recurrent GBM, gliosarcoma or wild-type IDH-1 anaplastic astrocytoma.
IV. To assess anti-tumoral activity and to determine progression-free survival (PFS) and overall survival (OS) after intra-arterial administration of BM-hMSCs-DNX2401 in patients with recurrent GBM, gliosarcoma or wild-type IDH-1 anaplastic astrocytoma.
OUTLINE: This is a dose-escalation study.
PART I: Patients receive one or two infusions of BM-hMSCs-DNX-2401 intra-arterially (IA) over 20-30 minutes on day 0. Dose level 1-5 will receive 1 infusion. Dose level 6 will receive 2 infusions.
PART II: Patients receive one or two infusions BM-hMSCs-DNX-2401 IA, depending on the highest dose that was tolerated in Part 1. After 2 weeks, patients undergo surgery where the tumor is removed, then receive intramural injection of BM-hMSCs-DNX-2401 into the resection cavity.
After completion of study treatment, patients in both part I and II are followed up on days 1, 4, 7, and 14 of month 1,every 6 weeks for 6 months (4 visits), then every 8 weeks for 1 year (6 visits), then every 4 months for 1 year (3 visits), then every 6 months until the tumor grows back. Patients treated at Dose level 6 in Part 1 and Part 2 are also followed up on Day 12, then on Day 1, 4, and 7 after second infusion, then on Day 1, 7, and 14 post-craniotomy for Part 2, Dose Level 6, then ,every 6 weeks for 6 months (4 visits), then every 8 weeks for 1 year (6 visits), then every 4 months for 1 year (3 visits), then every 6 months until the tumor grows back.
- Conditions
- IDH1 wt Allele, Recurrent Anaplastic Astrocytoma, Recurrent Glioblastoma, Recurrent Gliosarcoma, Recurrent Malignant Glioma
- Being tested
- Oncolytic Adenovirus Ad5-DNX-2401, Therapeutic Conventional Surgery
- Medical subject headings
- Astrocytoma, Glioblastoma, Gliosarcoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncolytic Adenovirus Ad5-DNX-2401Biological
Also called Ad5-Delta24RGD, DNX-2401, DNX2401, Oncolytic Ad5-Delta 24RGD
Given IA
Therapeutic Conventional SurgeryProcedure or surgery
Undergo surgery
| Study group | Role | What they receive |
|---|---|---|
| Part I (oncolytic adenovirus Ad5-DNX-2401) | Experimental | Patients receive oncolytic adenovirus Ad5-DNX-2401 IA over 20-30 minutes on day 0. Receives: Biological: Oncolytic Adenovirus Ad5-DNX-2401 |
| Part II (oncolytic adenovirus Ad5-DNX-2401, surgery) | Experimental | Patients receive oncolytic adenovirus Ad5-DNX-2401 as in part I. After 2 weeks, patients undergo surgery, then receive oncolytic adenovirus Ad5-DNX-2401 IA over 20-30 minutes. Receives: Biological: Oncolytic Adenovirus Ad5-DNX-2401; Procedure: Therapeutic Conventional Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum-tolerated dose (MTD)
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]).
Measured: Up to 28 days
Incidence of adverse events (AEs)
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.
Measured: Up to 1 year
Secondary outcomes (5)
Tumor response
Will be based upon change in tumor size by serial magnetic resonance imaging scans post injection.
Measured: Up to 1 year
Time to progression
Measured: Up to 1 year
Virus replication in tumor
Detection of replicating delta-24-RGD-4C in tumor tissue will be done by immunohistochemistry against E1A protein and hexon protein.
Measured: Up to 1 year
Virus shedding
Polymerase chain reaction of serum, nasopharyngeal secretions, and urine will be performed.
Measured: Up to 1 year
Immunogenicity based on adenoviral (AdV) antibodies
Enzyme-linked immunosorbent assay (ELISA) will be used to detect AdV antibodies in serum and virus assays to determine antibody titers (anti-AdV5 antibody immunofluorescence) will be performed.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start12 Feb 2019
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IDH1 wt AlleleStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- DNAtrix, Inc.
- Responsible party
- Sponsor
- Investigators
- Frederick F Lang, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03896568
- Sponsor's protocol ID
- 2015-0953
- Other IDs
- NCI-2019-01195, 2015-0953
- Status last verified
- Sep 2026
- First submitted
- 28 Mar 2019
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Chen SR, Chen MM, Ene C, Lang FF, Kan P. Perfusion-guided endovascular super-selective intra-arterial infusion for treatment of malignant brain tumors. J Neurointerv Surg. 2022 Jun;14(6):533-538. doi: 10.1136/neurintsurg-2021-018190. Epub 2021 Nov 25.
PubMed 34824133
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of Allogeneic Bone Marrow Human Mesenchymal Stem Cells Loaded With A Tumor Selective Oncolytic Adenovirus, DNX-2401, Administered Via Intra-Arterial Injection in Patients With Recurrent High-Grade Glioma
- ClinicalTrials.gov ID
- NCT03896568
- Acronym / sponsor ID
- 2015-0953
- Conditions
- IDH1 wt Allele, Recurrent Anaplastic Astrocytoma, Recurrent Glioblastoma, Recurrent Gliosarcoma, Recurrent Malignant Glioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- DNAtrix, Inc.
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 1 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To determine the maximal tolerated dose (MTD) of allogeneic bone marrow-derived human mesenchymal stem cells (BM-hMSCs) loaded with the oncolytic adenovirus DNX-2401 (BM-hMSCs-DNX2401) administered by intra-arterial injection (i.e., transfemoral endovascular intracranial injection) in patients with recurrent glioblastoma (GBM), IDH-mutant astrocytoma grade 4, gliosarcoma, or wild-type IDH-1 anaplastic astrocytoma.
II. To determine the local and systemic toxicity of allogeneic BM-hMSCs-DNX2401 administered by intra-arterial injection (i.e., transfemoral endovascular intracranial injection) in patients with recurrent GBM, gliosarcoma or wild-type IDH-1 anaplastic astrocytoma.
III. To determine at the molecular and cellular level the capacity of allogeneic BM-hMSCs-DNX2401 administered intra-arterially to home to and deliver DNX-2401 to recurrent GBM, gliosarcoma or wild-type IDH-1 anaplastic astrocytoma by analyzing post-treatment surgical brain tumor specimens for the expression and distribution of adenoviral proteins.
SECONDARY OBJECTIVES:
- To assess shedding of adenovirus into the blood, sputum, and nasopharynx after intra-arterial administration of BM-hMSCs-DNX2401 in patients with recurrent GBM, gliosarcoma or wild-type IDH-1 anaplastic astrocytoma.
II. To assess the development of anti-adenovirus antibodies after intra-arterial administration of BM-hMSCs-DNX2401 in patients with recurrent GBM, gliosarcoma or wild-type IDH-1 anaplastic astrocytoma.
III. To evaluate immune-mediated cytokine responses after intra-arterial administration of BM-hMSCs-DNX2401 in patients with recurrent GBM, gliosarcoma or wild-type IDH-1 anaplastic astrocytoma.
IV. To assess anti-tumoral activity and to determine progression-free survival (PFS) and overall survival (OS) after intra-arterial administration of BM-hMSCs-DNX2401 in patients with recurrent GBM, gliosarcoma or wild-type IDH-1 anaplastic astrocytoma.
OUTLINE: This is a dose-escalation study.
PART I: Patients receive one or two infusions of BM-hMSCs-DNX-2401 intra-arterially (IA) over 20-30 minutes on day 0. Dose level 1-5 will receive 1 infusion. Dose level 6 will receive 2 infusions.
PART II: Patients receive one or two infusions BM-hMSCs-DNX-2401 IA, depending on the highest dose that was tolerated in Part 1. After 2 weeks, patients undergo surgery where the tumor is removed, then receive intramural injection of BM-hMSCs-DNX-2401 into the resection cavity.
After completion of study treatment, patients in both part I and II are followed up on days 1, 4, 7, and 14 of month 1,every 6 weeks for 6 months (4 visits), then every 8 weeks for 1 year (6 visits), then every 4 months for 1 year (3 visits), then every 6 months until the tumor grows back. Patients treated at Dose level 6 in Part 1 and Part 2 are also followed up on Day 12, then on Day 1, 4, and 7 after second infusion, then on Day 1, 7, and 14 post-craniotomy for Part 2, Dose Level 6, then ,every 6 weeks for 6 months (4 visits), then every 8 weeks for 1 year (6 visits), then every 4 months for 1 year (3 visits), then every 6 months until the tumor grows back.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part I (oncolytic adenovirus Ad5-DNX-2401) | Experimental | Biological: Oncolytic Adenovirus Ad5-DNX-2401Patients receive oncolytic adenovirus Ad5-DNX-2401 IA over 20-30 minutes on day 0. |
| Part II (oncolytic adenovirus Ad5-DNX-2401, surgery) | Experimental | Biological: Oncolytic Adenovirus Ad5-DNX-2401, Procedure: Therapeutic Conventional SurgeryPatients receive oncolytic adenovirus Ad5-DNX-2401 as in part I. After 2 weeks, patients undergo surgery, then receive oncolytic adenovirus Ad5-DNX-2401 IA over 20-30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- Subjects must be willing and able to provide informed consent, undergo and comply with all study assessments, and adhere to the protocol schedule.
- Patients with recurrent malignant GBM or gliosarcoma will be eligible. Patients with recurrent anaplastic astrocytoma with wild-type IDH-1 gene will also be eligible if there is a significant enhancing mass on MRI (≥1.0 cm in diameter with upper limit of 5 cm maximal diameter) because their prognosis/behavior is similar to GBM. Subjects with an initial diagnosis of an IDH-mutant grade 2 or 3 astrocytoma are also eligible at recurrence if a biopsy at recurrence is determined to be IDH-mutant grade 4 astrocytoma, and there is a significant enhancing mass on MRI (≥1.0 cm in diameter with upper limit of 5 cm maximal diameter). A pathology report constitutes adequate documentation of histology for study inclusion.
- Patients must show unequivocal evidence for tumor recurrence or progression by MRI scan after failing prior surgical resection, biopsy, chemotherapy or radiation. A baseline MRI must be performed within 24 days prior to registration. Biopsy is encouraged at the time of recurrence if it is unclear that there is recurrent tumor. However, biopsy is not required if the practicing physician thinks that there is adequate radiographic and clinical evidence for recurrence.
- Male or female patients ≥ 18 years of age.
- Patients must be able to undergo endovascular treatment based on Doppler studies showing ICA that is less than 50% occluded.
Key exclusion criteria (24 listed)
- Histology other than GBM, gliosarcoma, IDH wild-type astrocytoma grade III or IDH-mutant astrocytoma grade 4.
- Tumor foci detected below the tentorium or beyond the cranial vault.
- Tumor within the posterior fossa.
- Tumor with leptomeningeal spread.
- Difficulty in obtaining vascular access for percutaneous procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oncolytic Adenovirus Ad5-DNX-2401Also: Ad5-Delta24RGD, DNX-2401, DNX2401, Oncolytic Ad5-Delta 24RGDGiven IA | Biological | Part I (oncolytic adenovirus Ad5-DNX-2401), Part II (oncolytic adenovirus Ad5-DNX-2401, surgery) |
| Therapeutic Conventional SurgeryUndergo surgery | Procedure or surgery | Part II (oncolytic adenovirus Ad5-DNX-2401, surgery) |
Primary outcome
Maximum-tolerated dose (MTD)
Time frame: 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)
Time frame: 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.
5 secondary outcomes
Tumor response
Time frame: Up to 1 year
Time to progression
Time frame: Up to 1 year
Virus replication in tumor
Time frame: Up to 1 year
Virus shedding
Time frame: Up to 1 year
Immunogenicity based on adenoviral (AdV) antibodies
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Derived from this study: PubMed 34824133Chen SR, Chen MM, Ene C, Lang FF, Kan P. Perfusion-guided endovascular super-selective intra-arterial infusion for treatment of malignant brain tumors. J Neurointerv Surg. 2022 Jun;14(6):533-538. doi: 10.1136/neurintsurg-2021-018190. Epub 2021 Nov 25.
- MD Anderson Cancer CenterLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frederick F Lang principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oncolytic Adenovirus Ad5-DNX-2401 and Therapeutic Conventional Surgery in people with IDH1 wt Allele and Recurrent Anaplastic Astrocytoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 37 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frederick Lang (713-792-2400, flang@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum-tolerated dose (MTD) (time frame: Up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03896568, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.