Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion

NCT01997190 ↗

Phase 1 Completed 19 enrolled Candel Therapeutics, Inc. University of Pennsylvania · collab

NaSingle-groupOpen-labelTreatment

Summary

This is a phase I study of intrapleural AdV-tk therapy in patients with malignant pleural effusion (MPE). The primary objective is to test the safety of intrapleural AdV-tk therapy. Secondary objectives are to evaluate clinical efficacy and biologic activity

Timeline

Start: 2013-10
Primary completion: 2015-12
Completion: 2018-02

Publications

Results Aggarwal C, Haas AR, Metzger S, Aguilar LK, Aguilar-Cordova E, Manzanera AG, Gomez-Hernandez G, Katz SI, Alley EW, Evans TL, Bauml JM, Cohen RB, Langer CJ, Albelda SM, Sterman DH. Phase I Study of Intrapleural Gene-Mediated Cytotoxic Immunotherapy in Patients with Malignant Pleural Effusion. Mol Ther. 2018 May 2;26(5):1198-1205. doi: 10.1016/j.ymthe.2018.02.015. Epub 2018 Feb 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	aglatimagene besadenovec	Unknown	1e+12 vg	Other
Subject	aglatimagene besadenovec	Unknown	1e+13 vg	Other
Background	Valacyclovir	Unknown	—	Oral

Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion

Summary

Timeline

Publications

Drugs

Indications