A Study to Evaluate CDX-301 (rhuFlt3L) in Healthy Volunteers

Phase 1 Completed 30 enrolled Celldex Therapeutics

Non-randomizedSingle-groupOpen-labelOther

Summary

CDX-301 is a protein that stimulates the growth of bone marrow stem cells and certain immune cells. This study is testing CDX-301 in healthy volunteers who will be monitored for safety and biological response for approximately one month or more.

Timeline

Start: 2011-10
Primary completion: 2012-11
Completion: 2013-01

Publications

Background Anandasabapathy N, Breton G, Hurley A, Caskey M, Trumpfheller C, Sarma P, Pring J, Pack M, Buckley N, Matei I, Lyden D, Green J, Hawthorne T, Marsh HC, Yellin M, Davis T, Keler T, Schlesinger SJ. Efficacy and safety of CDX-301, recombinant human Flt3L, at expanding dendritic cells and hematopoietic stem cells in healthy human volunteers. Bone Marrow Transplant. 2015 Jul;50(7):924-30. doi: 10.1038/bmt.2015.74. Epub 2015 Apr 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CDX-301	Protein / enzyme biologic	1 ug/kg	—
Subject	CDX-301	Protein / enzyme biologic	25 ug/kg	—
Subject	CDX-301	Protein / enzyme biologic	75 ug/kg	—

Indications

No indication recorded.