drugset / Trial / NCT03152318
A Study of the Treatment of Recurrent Malignant Glioma With rQNestin34.5v.2
Phase 1
Active not recruiting
62 enrolled
Dana-Farber Cancer Institute
Candel Therapeutics, Inc. · collabNational Institutes of Health (NIH) · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This research study is evaluating an investigational drug, an oncolytic virus called rQNestin34.5v.2. This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug as a possible treatment for this diagnosis of recurrent or progressive brain tumor.
Timeline
- Start
- 2017-07-18
- Primary completion
- 2027-01
- Completion
- 2028-01
Publications
- Meylan M, Tian Y, Wu L, Ling AL, Kovarsky D, Barlow GL, Nguyen LD, Pyrdol J, Marx S, Westphal L, Michel J, Gonzalez Castro LN, Dumont S, Santos A, Tirosh I, Suva ML, Chiocca EA, Wucherpfennig KW. Persistent T cell activation and cytotoxicity against glioblastoma following single oncolytic virus treatment in a clinical trial. Cell. 2026 Mar 5;189(5):1287-1304.e18. doi: 10.1016/j.cell.2025.12.055. Epub 2026 Feb 11.
- Noh MH, Kang JM, Miller AA, Nguyen G, Huang M, Shim JS, Bueso-Perez AJ, Murphy SA, Rivera-Caraballo KA, Otani Y, Kim E, Yoo SH, Yan Y, Banasavadi-Siddegowda Y, Nakashima H, Chiocca EA, Kaur B, Zhao Z, Lee TJ, Yoo JY. Targeting IGF2 to reprogram the tumor microenvironment for enhanced viro-immunotherapy. Neuro Oncol. 2024 Sep 5;26(9):1602-1616. doi: 10.1093/neuonc/noae105.
- Ling AL, Solomon IH, Landivar AM, Nakashima H, Woods JK, Santos A, Masud N, Fell G, Mo X, Yilmaz AS, Grant J, Zhang A, Bernstock JD, Torio E, Ito H, Liu J, Shono N, Nowicki MO, Triggs D, Halloran P, Piranlioglu R, Soni H, Stopa B, Bi WL, Peruzzi P, Chen E, Malinowski SW, Prabhu MC, Zeng Y, Carlisle A, Rodig SJ, Wen PY, Lee EQ, Nayak L, Chukwueke U, Gonzalez Castro LN, Dumont SD, Batchelor T, Kittelberger K, Tikhonova E, Miheecheva N, Tabakov D, Shin N, Gorbacheva A, Shumskiy A, Frenkel F, Aguilar-Cordova E, Aguilar LK, Krisky D, Wechuck J, Manzanera A, Matheny C, Tak PP, Barone F, Kovarsky D, Tirosh I, Suva ML, Wucherpfennig KW, Ligon K, Reardon DA, Chiocca EA. Clinical trial links oncolytic immunoactivation to survival in glioblastoma. Nature. 2023 Nov;623(7985):157-166. doi: 10.1038/s41586-023-06623-2. Epub 2023 Oct 18.
- Otani Y, Yoo JY, Lewis CT, Chao S, Swanner J, Shimizu T, Kang JM, Murphy SA, Rivera-Caraballo K, Hong B, Glorioso JC, Nakashima H, Lawler SE, Banasavadi-Siddegowda Y, Heiss JD, Yan Y, Pei G, Caligiuri MA, Zhao Z, Chiocca EA, Yu J, Kaur B. NOTCH-Induced MDSC Recruitment after oHSV Virotherapy in CNS Cancer Models Modulates Antitumor Immunotherapy. Clin Cancer Res. 2022 Apr 1;28(7):1460-1473. doi: 10.1158/1078-0432.CCR-21-2347.
- Chiocca EA, Nakashima H, Kasai K, Fernandez SA, Oglesbee M. Preclinical Toxicology of rQNestin34.5v.2: An Oncolytic Herpes Virus with Transcriptional Regulation of the ICP34.5 Neurovirulence Gene. Mol Ther Methods Clin Dev. 2020 Mar 30;17:871-893. doi: 10.1016/j.omtm.2020.03.028. eCollection 2020 Jun 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rQNestin | Unknown | 1e+07 unknown | Other |
| Subject | rQNestin | Unknown | 1e+08 unknown | Other |
| Subject | rQNestin | Unknown | 1e+09 unknown | Other |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |