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Trial record 1 of 1 for:    MRG106
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Safety, Tolerability and Pharmacokinetic Study of MRG-106 in Patients With Cutaneous T Cell Lymphoma (CTCL), MF Subtype

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by miRagen Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
miRagen Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02580552
First received: October 15, 2015
Last updated: February 23, 2017
Last verified: December 2016
  Purpose
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.

Condition Intervention Phase
Cutaneous T-cell Lymphoma (CTCL)
Mycosis Fungoides
Drug: MRG-106
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by miRagen Therapeutics, Inc.:

Primary Outcome Measures:
  • Safety and tolerability of MRG-106 based on vital signs, physical examination, clinical laboratory tests, ECG, and incidence and severity of adverse events [ Time Frame: Up to 56 days ]

Secondary Outcome Measures:
  • Area under the plasma concentration vs. time curve (AUC) of MRG-106 following single and repeat doses administered intratumorally, subcutaneously or intravenously [ Time Frame: Up to 56 days ]
  • Peak plasma concentration (Cmax) of MRG-106 following single and repeat doses administered intratumorally, subcutaneously or intravenously [ Time Frame: Up to 56 days ]

Other Outcome Measures:
  • Exploratory assessment of changes in lesion severity before and after treatment based on the Composite Assessment of Index Lesion Severity (CAILS) scoring tool [ Time Frame: Up to 56 days ]
  • Exploratory assessment of changes in lesion severity before and after treatment based on the modified Severity Weighted Assessment Tool (mSWAT) [ Time Frame: Up to 56 days ]
  • Exploratory assessment of miR-155-5p expression in CTCL cutaneous lesions based on quantitative real time polymerase chain reaction (qRT-PCR) analysis of total RNA isolated from skin biopsies [ Time Frame: Up to 56 days ]
  • Exploratory histological assessment of CD4+ cells in CTCL cutaneous lesions before and after treatment [ Time Frame: Up to 56 days ]

Estimated Enrollment: 50
Study Start Date: November 2015
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part A, MRG-106
Intratumoral Injection
Drug: MRG-106
Decreasing intratumoral doses
Experimental: Part B, MRG-106
Subcutaneous Injection or Intravenous Infusion
Drug: MRG-106
Escalating subcutaneous or intravenous doses with starting dose selected based on MRG-106 tolerability determined in Part A

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with biopsy proven CTCL, MF sub-type, clinical stage I, II, or III, who are clinically stable and on a stable treatment regimen for ≥ 4 weeks
  • Patients must be refractory to or intolerant of established therapies for their condition
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Females must not be pregnant or lactating. Women of child-bearing potential must use a highly effective method of contraception throughout their study participation and for at least 6 months following the last dose of study drug
  • Males must be surgically sterile, abstinent, or willing to use an acceptable double-barrier method of contraception during treatment and for at least 6 months after the last dose of study drug

Exclusion Criteria:

  • Evidence of visceral involvement related to CTCL
  • History of renal or liver dysfunction or evidence of renal or liver dysfunction at screening
  • History of hematological abnormalities (e.g., coagulopathy) or evidence of hematological abnormalities at screening
  • Positive at time of screening for HIV, Hepatitis B surface antigen, Hepatitis C
  • Prior malignancies within the past 3 years (with allowance for squamous cell and basal cell carcinomas with free margins at excision)
  • Use of an investigational small molecule drug during the 30 days prior to screening or use of an investigational oligonucleotide or biologic drug during the prior 90 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02580552

Contacts
Contact: miRagen Therapeutics, Inc. 720-407-4603

Locations
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Christiane Querfeld, MD    626-256-4673    cquerfeld@coh.org   
Contact: Donna Bui    626-256-4673 ext 61987    dbui@coh.org   
Principal Investigator: Christiane Querfeld, MD         
UCLA Department of Medicine Recruiting
Los Angeles, California, United States, 90095
Contact: Jonsson Comprehensive Cancer Center Clinical Research Unit    310-794-6500      
Principal Investigator: Herbert Eradat, MD         
Chao Family Comprehensive Cancer Center at University of California, Irvine Recruiting
Orange, California, United States, 92868
Contact    877-827-8839    ucstudy@uci.edu   
Principal Investigator: Lauren Pinter-Brown, MD         
Stanford University Hospital and Clinics Recruiting
Stanford, California, United States, 94063
Contact: Christine Cheung    650-725-1202    ccheung7@stanford.edu   
Contact: Youn Kim, MD    650-498-6000      
Principal Investigator: Youn Kim, MD         
United States, Colorado
University of Colorado, Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Sam Fox    720-848-8846    sam.fox@ucdenver.edu   
Contact: Jacquelyn Friebel, CCRP    720-848-0741    jacquelyn.friebel@ucdenver.edu   
Principal Investigator: Theresa R. Pacheco, MD         
United States, Connecticut
Smilow Cancer Hospital at Yale-New Haven Recruiting
New Haven, Connecticut, United States, 06510
Contact: Francine Foss, MD    203-737-5312    Francine.Foss@yale.edu   
Contact: Anne Caldwell, RN, BSN, OCN    203-785-3465      
Principal Investigator: Francine Foss, MD         
United States, Illinois
Northwestern University; Department of Dermatology Recruiting
Chicago, Illinois, United States, 60611
Contact: Stephanie Rangel, PhD    312-695-6829    stephanie.rangel@northwestern.edu   
Principal Investigator: Joan Guitart, MD         
United States, Ohio
The Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Juliana Engleman    614-685-6005    Juliana.Engleman@osumc.edu   
Principal Investigator: Basem William, MD         
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Carol Wilson, RN    713-563-4655    clwilson@mdanderson.org   
Principal Investigator: Auris Huen, MD         
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Ahmad Halwani, MD    801-581-4477    clinical.trials@hci.utah.edu   
Principal Investigator: Ahmad Halwani, MD         
United States, Virginia
Inova Melanoma and Skin Cancer Center / Inova Schar Cancer Institute Recruiting
Fairfax, Virginia, United States, 22003
Contact: Kelly Jeffords, CCRC, CCRP    703-208-6606    kelly.jeffords@inova.org   
Principal Investigator: Jennifer DeSimone, MD         
Sponsors and Collaborators
miRagen Therapeutics, Inc.
Investigators
Study Director: Paul Rubin, MD miRagen Therapeutics, Inc.
  More Information

Publications:
Responsible Party: miRagen Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02580552     History of Changes
Other Study ID Numbers: MRG106-11-101
Study First Received: October 15, 2015
Last Updated: February 23, 2017

Keywords provided by miRagen Therapeutics, Inc.:
Cutaneous T-cell Lymphoma
CTCL
Mycosis Fungoides

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Mycoses
Mycosis Fungoides
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on May 25, 2017