The DOI matches its Crossref record; 3 of the 3 references it cites were found in a registry or an index.
Phase I Study of DNX-2401 (Delta-24-RGD) Oncolytic Adenovirus: Replication and Immunotherapeutic Effects in Recurrent Malignant Glioma
Open accessAbstract
Purpose: DNX-2401 (Delta-24-RGD; tasadenoturev) is a tumor-selective, replication-competent oncolytic adenovirus. Preclinical studies demonstrated antiglioma efficacy, but the effects and mechanisms of action have not been evaluated in patients. Methods: A phase I, dose-escalation, biologic-end-point clinical trial of DNX-2401 was conducted in 37 patients with recurrent malignant glioma. Patients received a single intratumoral injection of DNX-2401 into biopsy-confirmed recurrent tumor to evaluate safety and response across eight dose levels (group A). To investigate the mechanism of action, a second group of patients (group B) underwent intratumoral injection through a permanently implanted catheter, followed 14 days later by en bloc resection to acquire post-treatment specimens. Results: In group A (n = 25), 20% of patients survived > 3 years from treatment, and three patients had a ≥ 95% reduction in the enhancing tumor (12%), with all three of these dramatic responses resulting in > 3 years of progression-free survival from the time of treatment. Analyses of post-treatment surgical specimens (group B, n = 12) showed that DNX-2401 replicates and spreads within the tumor, documenting direct virus-induced oncolysis in patients. In addition to radiographic signs of inflammation, histopathologic examination of immune markers in post-treatment specimens showed tumor infiltration by CD8+ and T-bet+ cells, and transmembrane immunoglobulin mucin-3 downregulation after treatment. Analyses of patient-derived cell lines for damage-associated molecular patterns revealed induction of immunogenic cell death in tumor cells after DNX-2401 administration. Conclusion: Treatment with DNX-2401 resulted in dramatic responses with long-term survival in recurrent high-grade gliomas that are probably due to direct oncolytic effects of the virus followed by elicitation of an immune-mediated antiglioma response.
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Molecular and cellular insights into T cell exhaustion
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“Median age, years (range) 52 (21-62) 49 (29-60) Sex Male 15 (60) 6 (50) Female 10 (40) 6 (50) Karnofsky performance scale score 90-100 20 (80) 8 (67) 70-80 5 (20) 4 (33) Histology Glioblastoma, primary 21 (84) 7 (58) Glioblastoma, secondary 3 (12) 2 (16) Gliosarcoma 0 (0) 2 (17) Anaplastic astrocytoma 1 (4) 1 (8) Medi…”
Response criteria for phase II studies of supratentorial malignant glioma.
Macdonald, D. R., Cascino, T. L., Schold, S. C., & Cairncross, J. G. (1990) · Journal of Clinical Oncology · doi:10.1200/jco.1990.8.7.1277 · Cited by 2,409
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Wen, P. Y., Weller, M., Lee, E. Q., Alexander, B. M., Barnholtz-Sloan, J. S., Barthel, F. P., Batchelor, T. T., Bindra, R. S., Chang, S. M., Chiocca, E. A., et al. (2020) · Neuro-Oncology · doi:10.1093/neuonc/noaa106 · Cited by 1,168
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Metadata
- Authors
- Lang, F. F., Conrad, C., Gomez-Manzano, C., Yung, W. K. A., Sawaya, R., Weinberg, J. S., Prabhu, S. S., Rao, G., Fuller, G. N., Aldape, K. D., Gumin, J., Vence, L. M., Wistuba, I., Rodriguez-Canales, J., Villalobos, P. A., Dirven, C. M. F., Tejada, S., Valle, R. D., Alonso, M. M., Ewald, B., Peterkin, J. J., Tufaro, F., & Fueyo, J.
- Venue
- Journal of Clinical Oncology
- Published
- 2018-05-10
- Volume
- 36
- Issue
- 14
- Pages
- 1419-1427
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2787278337
- Cited by
- 711
- References
- 3
- FWCI
- 39.15
- Type
- journal article
- Language
- en
- Open access
- green
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- Lang, F. F., Conrad, C., Gomez-Manzano, C., Yung, W. K. A., Sawaya, R., Weinberg, J. S., Prabhu, S. S., Rao, G., Fuller, G. N., Aldape, K. D., Gumin, J., Vence, L. M., Wistuba, I., Rodriguez-Canales, J., Villalobos, P. A., Dirven, C. M. F., Tejada, S., Valle, R. D., Alonso, M. M., . . . Fueyo, J. (2018). Phase I Study of DNX-2401 (Delta-24-RGD) Oncolytic Adenovirus: Replication and Immunotherapeutic Effects in Recurrent Malignant Glioma. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2017.75.8219
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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