CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 36 target
Drug / intervention
Oncolytic Adenovirus Ad5-DNX-2401 +1 morebiological
Likely dose
Not stated in record
Key inclusion· 16
  • ✓Recurrent malignant GBM, gliosarcoma, or IDH-wt anaplastic astrocytoma (if enhancing mass ≥1.0 cm, ≤5 cm)
  • ✓IDH-mutant grade 2 or 3 astrocytoma eligible if biopsy at recurrence shows IDH-mutant grade 4 with enhancing mass ≥1.0–5 cm
  • ✓Unequivocal evidence of tumor recurrence/progression on MRI after prior surgery, biopsy, chemotherapy, or radiation
  • ✓Age ≥18 years
Key exclusion· 24
  • ✕Histology other than GBM, gliosarcoma, IDH-wt grade III astrocytoma, or IDH-mutant grade 4 astrocytoma
  • ✕Tumor below tentorium or beyond cranial vault
  • ✕Tumor in posterior fossa
  • ✕Leptomeningeal spread

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03896568
NCT03896568Phase 1RecruitingOn TrackUpdated 3mo ago
Long Recruiting
CompareCT.gov

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

M.D. Anderson Cancer Center·interventional·Posted Apr 1, 2019·Updated Mar 5, 2026

In Brief

A Phase 1 clinical trial evaluating Oncolytic Adenovirus Ad5-DNX-2401 and Therapeutic Conventional Surgery for IDH1 wt Allele and 4 related conditions. Currently recruiting, targeting 36 participants across 1 site.

Detailed 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 as a cold). The virus is also changed to target brain cancer cells and attack them.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIDH1 wt Allele, Recurrent Anaplastic Astrocytoma, Recurrent Glioblastoma, Recurrent Gliosarcoma, Recurrent Malignant Glioma
CountriesUnited States
CollaboratorsDNAtrix, Inc.

Timeline

Phase 1Recruiting
201920202021202220232024202520262027
First PostedApr 1, 2019
Enrollment StartFeb 12, 2019
Primary CompletionSep 30, 2027
TodayJul 2, 2026
Enrollment to primary: 8.6 yearsPosted 7.3 years agoPrimary completion in 1.2 years

Interventions

Oncolytic Adenovirus Ad5-DNX-2401biological

Given IA

Therapeutic Conventional Surgeryprocedure

Undergo surgery