Last updated on February 2017

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


Brief description of study

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.

Detailed Study Description

Study Design: - Part A: Cohorts of 3-6 patients will receive up to five intratumoral injections of MRG-106 over a period of up to 15 days with follow-up for an additional 20 days, beginning with the maximum deliverable intratumoral dose. Doses may be decreased in subsequent cohorts to determine the minimum pharmacodynamically active dose. - Part B: Cohorts of 3-6 patients will receive six subcutaneous or intravenous doses of MRG-106 over 26 days, with follow-up through 56 days. The starting dose will be selected based on the tolerability of MRG-106 determined in Part A. Doses may be escalated in subsequent cohorts to determine the maximum tolerated dose. - Patients in Part B for whom MRG-106 is well tolerated may continue on their assigned dose in an extension period of the study at the discretion of the investigator and the sponsor. - Any cohort in Part A or Part B may be expanded to further elucidate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of MRG-106.

Clinical Study Identifier: NCT02580552

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Christiane Querfeld, MD

City of Hope
Duarte, CA United States
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Herbert Eradat, MD

UCLA Department of Medicine
Los Angeles, CA United States
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Lauren Pinter-Brown, MD

Chao Family Comprehensive Cancer Center at University of California, Irvine
Orange, CA United States
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Youn Kim, MD

Stanford University Hospital and Clinics
Stanford, CA United States
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Theresa R. Pacheco, MD

University of Colorado, Anschutz Medical Campus
Aurora, CO United States
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Francine Foss, MD

Smilow Cancer Hospital at Yale-New Haven
New Haven, CT United States
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Joan Guitart, MD

Northwestern University; Department of Dermatology
Chicago, IL United States
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Basem William, MD

The Ohio State University Comprehensive Cancer Center
Columbus, OH United States
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Auris Huen, MD

The University of Texas MD Anderson Cancer Center
Houston, TX United States
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Ahmad Halwani, MD

Huntsman Cancer Institute
Salt Lake City, UT United States
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Jennifer DeSimone, MD

Inova Melanoma and Skin Cancer Center / Inova Schar Cancer Institute
Fairfax, VA United States
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