Safety, Tolerability and Pharmacokinetic Study of MRG-106 in Patients With Cutaneous T Cell Lymphoma (CTCL), MF Subtype

This study is currently recruiting participants.

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 or by intravenous infusion. 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.

Study Type:  Interventional

Study Design:  

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Official Title:  A Phase 1 Dose-ranging Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MRG-106 Following Local Intratumoral, Subcutaneous, and Intravenous Injection in Patients With Cutaneous T Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Sub-type

Conditions:  

Cutaneous T-cell Lymphoma (CTCL)
Mycosis Fungoides

Interventions:  Drug: MRG-106

Phase:  Phase 1

External Link:  https://clinicaltrials.gov/ct2/show/NCT02580552