Back to resultsSafety, Tolerability and Pharmacokinetics of MRG-106 in Patients With Mycosis Fungoides (MF), CLL, DLBCL or ATLL
Primary Purpose
Cutaneous T-cell Lymphoma (CTCL), Mycosis Fungoides (MF), Chronic Lymphocytic Leukemia (CLL)
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cobomarsen
Sponsored by
About this trial
This is an interventional treatment trial for Cutaneous T-cell Lymphoma (CTCL) focused on measuring Cutaneous T-cell Lymphoma, CTCL, Mycosis Fungoides, Chronic lymphocytic leukemia, CLL, Diffuse large B-cell lymphoma, DLBCL, Adult T-cell leukemia/lymphoma, ATLL
Eligibility Criteria
Inclusion Criteria:
- Parts A-C only: Patients must have biopsy proven MF, clinical stage I, II, or III (excluding visceral or nodal involvement), and must be refractory to or intolerant of established therapies for their condition
- Part D only: Patients diagnosed with CLL who are intolerant to, or have disease that is relapsed/refractory after, at least two prior therapies
- Part E only: Patients with biopsy-proven DLBCL who are intolerant to, or have disease that is relapsed/refractory after, at least two prior therapies, including any anti-CD20 monoclonal antibody and chemotherapy with curative intent
- Part F only: Patients with documented HTLV-1 infection and histologically or cytologically proven ATLL of any stage, and who are intolerant to, or have disease that is relapsed/refractory after, at least one prior therapy
- 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 if engaged in sexual relations with a female of child-bearing potential, must be willing to use a highly effective method of contraception throughout their study participation and for at least 6 months after the last dose of study drug.
Exclusion Criteria:
- Evidence of renal or liver dysfunction at screening
- Clinically significant anemia, neutropenia or thrombocytopenia at screening
- History of bleeding diathesis or coagulopathy
- Clinically significant cardiovascular disease, history of myocardial infarction within the last 6 months, or evidence of QTc interval prolongation at screening
- Serologically positive for HIV; serologically positive for Hepatitis B or Hepatitis C with evidence of liver dysfunction or documented liver cirrhosis
- Prior malignancies within the past 3 years (with allowance for adequately treated in situ carcinoma of the cervix uteri, and basal cell or localized squamous cell carcinoma of the skin treated with curative intent)
- 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
Sites / Locations
- City of Hope
- UCSD Moores Cancer Center
- UCLA Department of Medicine
- Chao Family Comprehensive Cancer Center at University of California, Irvine
- Stanford University Hospital and Clinics
- University of Colorado, Anschutz Medical Campus
- Smilow Cancer Hospital at Yale-New Haven
- University of Miami Sylvester Comprehensive Cancer Center
- Northwestern University; Department of Dermatology
- Beth Israel Deaconess Medical Center
- University of Nebraska Medical Center
- Montefiore Medical Center, Albert Einstein College of Medicine
- Memorial Sloan Kettering Cancer Center
- Weill Cornell Medicine
- The Ohio State University Comprehensive Cancer Center
- Thomas Jefferson University Hospital
- The University of Texas MD Anderson Cancer Center
- Huntsman Cancer Institute
- Inova Melanoma and Skin Cancer Center / Inova Schar Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Part A, MF
Part B, MF
Part C, MF
Part D, CLL
Part E, DLBCL, activated B-cell (ABC) subtype
Part F, ATLL
Arm Description
Intratumoral Injection of cobomarsen
Subcutaneous, intravenous or a combination of systemic and intratumoral administration of cobomarsen with or without stable background therapy
Subcutaneous or intravenous administration of cobomarsen as monotherapy
Subcutaneous or intravenous administration of cobomarsen as monotherapy
Subcutaneous or intravenous administration of cobomarsen as monotherapy
Subcutaneous or intravenous administration of cobomarsen as monotherapy
Outcomes
Primary Outcome Measures
Safety and tolerability of cobomarsen based on vital signs, physical examination, clinical laboratory tests, ECG, and incidence and severity of adverse events
Secondary Outcome Measures
Area under the plasma concentration vs. time curve (AUC) of cobomarsen following single and repeat doses administered intratumorally, subcutaneously or intravenously
Peak plasma concentration (Cmax) of cobomarsen following single and repeat doses administered intratumorally, subcutaneously or intravenously
Trough plasma concentration (Ctrough) of cobomarsen following each 4-week cycle of dosing
Skin disease severity (index lesions) - MF only
Changes in MF skin lesion severity before and after treatment based on the Composite Assessment of Index Lesion Severity (CAILS) score
Skin disease severity (whole body) - MF only
Changes in MF skin lesion severity before and after treatment based on the modified Severity Weighted Assessment Tool (mSWAT) score
Overall Response Rate in the skin - MF
Proportion of subjects who achieve a partial response (PR) or complete response (CR) in the skin, based on SWAT score
Overall Response Rate - CLL
Proportion of subjects who achieve a PR or CR as defined by IWCLL criteria (Hallek et al., 2008) based on CT scans, bone marrow biopsies, and flow cytometry
Minimal Residual Disease (MRD) - CLL only
Proportion of subjects who achieve a CR with no evidence of MRD by flow cytometry
Overall Response Rate - DLBCL
Proportion of subjects who achieve a PR or CR as defined by the Lugano classification (Cheson et al., 2014) based on positron emission tomography-computed tomography (PET-CT) scans and bone marrow biopsy to confirm CR
Overall Response Rate - ATLL
Proportion of subjects who achieve a PR or CR as defined by international consensus criteria (Tsukasaki et al., 2009) based on CT scans and flow cytometry, and bone marrow biopsy to confirm CR
Duration of Response
Number of days from initial date of confirmed PR or CR until loss of response or relapse
Time to Progression
Number of days from first dose until objective disease progression
Progression Free Survival (PFS)
Number of days from first dose until objective disease progression or death from any cause
Overall Survival (OS)
Number of days from first dose until death from any cause
Full Information
NCT ID
NCT02580552
First Posted
October 15, 2015
Last Updated
November 19, 2020
Sponsor
miRagen Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02580552
Brief Title
Safety, Tolerability and Pharmacokinetics of MRG-106 in Patients With Mycosis Fungoides (MF), CLL, DLBCL or ATLL
Official Title
A Phase 1 Dose-ranging Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MRG-106 Following Local Intratumoral, Subcutaneous, and Intravenous Administration in Subjects With Various Lymphomas and Leukemias
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 9, 2016 (Actual)
Primary Completion Date
October 6, 2020 (Actual)
Study Completion Date
October 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
miRagen Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Objectives of this clinical trial are to evaluate the safety, tolerability, pharmacokinetics and potential efficacy of the investigational drug, cobomarsen (MRG-106), in patients diagnosed with certain lymphomas and leukemias, including cutaneous T-cell lymphoma (CTCL) [mycosis fungoides (MF) subtype], chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL) [activated B-cell (ABC) subtype], and adult T-cell leukemia/lymphoma (ATLL). Cobomarsen is an inhibitor of a molecule called miR-155 that is found at high levels in these types of cancers and may be important in promoting the growth and survival of the cancer cells. Participants in the clinical trial will receive weekly doses of cobomarsen administered by injection under the skin or into a vein, or by injection directly into cancerous lesions in the skin (for CTCL only). Blood samples will be collected to measure how cobomarsen is processed by the body, and other measurements will be performed to study how normal and cancerous cells of the immune system respond when exposed to cobomarsen.
Detailed Description
Study Design:
Part A: Cohorts of 3-6 patients diagnosed with MF will receive up to five intratumoral injections of cobomarsen 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.
Parts B-F: Patients in these parts of the study will be diagnosed with MF (Parts B and C), CLL (Part D), DLBCL (Part E), or ATLL (Part F). All patients will receive subcutaneous or intravenous cobomarsen (or a combination of systemic and intratumoral administration for MF patients only) on Days 1, 3 and 5, and will continue dosing on a weekly schedule until the patient becomes intolerant, develops clinically significant side effects, progresses, or the trial is terminated. Doses administered will not exceed a dose level predicted to be safe based on all prior treatment experience with the drug. Patients in Part B may continue on a stable background therapy for their disease during their treatment with cobomarsen, while patients in Parts C-F will be treated with cobomarsen alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous T-cell Lymphoma (CTCL), Mycosis Fungoides (MF), Chronic Lymphocytic Leukemia (CLL), Diffuse Large B-Cell Lymphoma (DLBCL), ABC Subtype, Adult T-Cell Leukemia/Lymphoma (ATLL)
Keywords
Cutaneous T-cell Lymphoma, CTCL, Mycosis Fungoides, Chronic lymphocytic leukemia, CLL, Diffuse large B-cell lymphoma, DLBCL, Adult T-cell leukemia/lymphoma, ATLL
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part A, MF
Arm Type
Experimental
Arm Description
Intratumoral Injection of cobomarsen
Arm Title
Part B, MF
Arm Type
Experimental
Arm Description
Subcutaneous, intravenous or a combination of systemic and intratumoral administration of cobomarsen with or without stable background therapy
Arm Title
Part C, MF
Arm Type
Experimental
Arm Description
Subcutaneous or intravenous administration of cobomarsen as monotherapy
Arm Title
Part D, CLL
Arm Type
Experimental
Arm Description
Subcutaneous or intravenous administration of cobomarsen as monotherapy
Arm Title
Part E, DLBCL, activated B-cell (ABC) subtype
Arm Type
Experimental
Arm Description
Subcutaneous or intravenous administration of cobomarsen as monotherapy
Arm Title
Part F, ATLL
Arm Type
Experimental
Arm Description
Subcutaneous or intravenous administration of cobomarsen as monotherapy
Intervention Type
Drug
Intervention Name(s)
Cobomarsen
Other Intervention Name(s)
MRG-106
Primary Outcome Measure Information:
Title
Safety and tolerability of cobomarsen based on vital signs, physical examination, clinical laboratory tests, ECG, and incidence and severity of adverse events
Time Frame
From start of treatment to end of study participation
Secondary Outcome Measure Information:
Title
Area under the plasma concentration vs. time curve (AUC) of cobomarsen following single and repeat doses administered intratumorally, subcutaneously or intravenously
Time Frame
Up to 56 days
Title
Peak plasma concentration (Cmax) of cobomarsen following single and repeat doses administered intratumorally, subcutaneously or intravenously
Time Frame
Up to 56 days
Title
Trough plasma concentration (Ctrough) of cobomarsen following each 4-week cycle of dosing
Time Frame
Monthly from Week 5 up to end of study participation
Title
Skin disease severity (index lesions) - MF only
Description
Changes in MF skin lesion severity before and after treatment based on the Composite Assessment of Index Lesion Severity (CAILS) score
Time Frame
Every 2 weeks from start of treatment until end of study participation
Title
Skin disease severity (whole body) - MF only
Description
Changes in MF skin lesion severity before and after treatment based on the modified Severity Weighted Assessment Tool (mSWAT) score
Time Frame
Every 2 weeks from start of treatment until end of study participation
Title
Overall Response Rate in the skin - MF
Description
Proportion of subjects who achieve a partial response (PR) or complete response (CR) in the skin, based on SWAT score
Time Frame
Approximately 1 year
Title
Overall Response Rate - CLL
Description
Proportion of subjects who achieve a PR or CR as defined by IWCLL criteria (Hallek et al., 2008) based on CT scans, bone marrow biopsies, and flow cytometry
Time Frame
Approximately 1 year
Title
Minimal Residual Disease (MRD) - CLL only
Description
Proportion of subjects who achieve a CR with no evidence of MRD by flow cytometry
Time Frame
Approximately 1 year
Title
Overall Response Rate - DLBCL
Description
Proportion of subjects who achieve a PR or CR as defined by the Lugano classification (Cheson et al., 2014) based on positron emission tomography-computed tomography (PET-CT) scans and bone marrow biopsy to confirm CR
Time Frame
Approximately 1 year
Title
Overall Response Rate - ATLL
Description
Proportion of subjects who achieve a PR or CR as defined by international consensus criteria (Tsukasaki et al., 2009) based on CT scans and flow cytometry, and bone marrow biopsy to confirm CR
Time Frame
Approximately 1 year
Title
Duration of Response
Description
Number of days from initial date of confirmed PR or CR until loss of response or relapse
Time Frame
Up to approximately 2 years
Title
Time to Progression
Description
Number of days from first dose until objective disease progression
Time Frame
Up to approximately 2 years
Title
Progression Free Survival (PFS)
Description
Number of days from first dose until objective disease progression or death from any cause
Time Frame
Up to approximately 2 years
Title
Overall Survival (OS)
Description
Number of days from first dose until death from any cause
Time Frame
Up to approximately 2 years
Other Pre-specified Outcome Measures:
Title
miR-155-5p expression in cutaneous lesions of subjects with MF
Description
Exploratory assessment based on quantitative real time polymerase chain reaction (qRT-PCR) analysis of total RNA isolated from skin biopsies
Time Frame
At baseline and between Week 16 and end of study participation
Title
Proportion of neoplastic lymphoid cells in cutaneous lesions of subjects with MF
Description
Exploratory histological assessment before and after treatment with cobomarsen
Time Frame
At baseline and between Week 16 and end of study participation
Title
Proportions of immune cell subsets
Description
Exploratory assessment before and after treatment with cobomarsen by flow cytometry on whole blood
Time Frame
At baseline and monthly or bimonthly, up to end of study participation
Title
Dermatology-specific quality of life - MF only
Description
Changes in skin-related quality of life based on the Skindex-29 assessment tool
Time Frame
At baseline and monthly, up to approximately 2 years
Title
Pruritus - MF only
Description
Changes in intensity of skin itch based on the Pruritus Numerical Rating Scale
Time Frame
At baseline and monthly, up to approximately 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parts A-C only: Patients must have biopsy proven MF, clinical stage I, II, or III (excluding visceral or nodal involvement), and must be refractory to or intolerant of established therapies for their condition
Part D only: Patients diagnosed with CLL who are intolerant to, or have disease that is relapsed/refractory after, at least two prior therapies
Part E only: Patients with biopsy-proven DLBCL who are intolerant to, or have disease that is relapsed/refractory after, at least two prior therapies, including any anti-CD20 monoclonal antibody and chemotherapy with curative intent
Part F only: Patients with documented HTLV-1 infection and histologically or cytologically proven ATLL of any stage, and who are intolerant to, or have disease that is relapsed/refractory after, at least one prior therapy
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 if engaged in sexual relations with a female of child-bearing potential, must be willing to use a highly effective method of contraception throughout their study participation and for at least 6 months after the last dose of study drug.
Exclusion Criteria:
Evidence of renal or liver dysfunction at screening
Clinically significant anemia, neutropenia or thrombocytopenia at screening
History of bleeding diathesis or coagulopathy
Clinically significant cardiovascular disease, history of myocardial infarction within the last 6 months, or evidence of QTc interval prolongation at screening
Serologically positive for HIV; serologically positive for Hepatitis B or Hepatitis C with evidence of liver dysfunction or documented liver cirrhosis
Prior malignancies within the past 3 years (with allowance for adequately treated in situ carcinoma of the cervix uteri, and basal cell or localized squamous cell carcinoma of the skin treated with curative intent)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana M. Escolar, MD, FAAN
Organizational Affiliation
miRagen Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
UCSD Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
UCLA Department of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center at University of California, Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Stanford University Hospital and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
University of Colorado, Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Smilow Cancer Hospital at Yale-New Haven
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
University of Miami Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Northwestern University; Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Montefiore Medical Center, Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
The Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Inova Melanoma and Skin Cancer Center / Inova Schar Cancer Institute
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Learn more about this trial
Safety, Tolerability and Pharmacokinetics of MRG-106 in Patients With Mycosis Fungoides (MF), CLL, DLBCL or ATLL
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