A Phase I Dose-ranging Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MRG-106 Following Local Intratumoral and Subcutaneous Injection in Patients With Cutaneous T Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Sub-type
Mycosis Fungoides | Phase I
What is the purpose of this trial?
The primary objective of this study is to evaluate the safety and tolerability of the investigational drug, MRG-106, in patients with cutaneous T-cell lymphoma (CTCL), mycosis fungoides subtype. MRG-106 is an inhibitor of a molecule called miR-155 that is found at high levels in the malignant T-cells of many mycosis fungoides patients. miR-155 may be important in promoting the growth and survival of these cancer cells. In Part A of the study, MRG-106 will be tested by injection directly into CTCL lesions in the skin. In Part B of the study, MRG-106 will be given by subcutaneous injection. Other objectives of the study are to measure the absorption and clearance of MRG-106 from the blood, and to understand how cells in CTCL skin lesions respond when exposed to MRG-106.
- Trial withmiRagen Therapeutics, Inc.
- Start Date01/24/2016
- End Date11/30/2018
- Last Updated04/05/2018
- Study HIC#1507016232