A Phase 2 interventional study of Cobomarsen in Cutaneous T-Cell Lymphoma/Mycosis Fungoides, sponsored by miRagen Therapeutics, Inc.. Terminated at 9 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-19.
Sponsored by miRagen Therapeutics, Inc. · Phase 2, Interventional, and Treatment
The main objective of this clinical trial is to study the efficacy and safety of cobomarsen (also known as MRG-106) for the treatment of cutaneous T-cell lymphoma (CTCL), mycosis fungoides (MF) subtype in subjects who have confirmed disease progression following treatment with vorinostat in the SOLAR clinical study (MRG106-11-201). Cobomarsen is designed to inhibit the activity of a molecule called miR-155 that may be important to the growth and survival of MF cancer cells.
The effects of treatment will be measured based on changes in skin lesion severity, disease-associated symptoms, and quality of life, as well as the length of time that the subject's disease remains stable or improved, without evidence of disease progression. The safety and tolerability of cobomarsen will be assessed based on the frequency and severity of observed side effects.
Study Design:
Up to 60 subjects are expected to be enrolled after discontinuation from the SOLAR clinical study (MRG106-11-201). Cobomarsen will be administered in the clinic by 2-hr intravenous infusion on Days 1, 3, 5 and 8, and weekly thereafter. Treatment will continue until the subject becomes intolerant, develops clinically significant side effects, progresses, or the trial is terminated.
447 studies on the registry are indexed under Mycosis Fungoides; 42 are open to participants now.
This study's enrollment of 8 is below the median of 34 across 321 interventional studies indexed under Mycosis Fungoides.
Browse Mycosis Fungoides studies →miRagen Therapeutics, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Cobomarsen
At least weekly intravenous infusions of cobomarsen (282 mg) throughout study treatment period
Also known as: MRG-106
Proportion of subjects achieving an objective response of at least 4 months duration (ORR4)
Based on composite global response criteria including radiological imaging, flow cytometry, and the modified Severity Weighted Assessment Tool (mSWAT).
Time frame: Up to approximately 36 months (estimated study duration)
Progression-free survival
Time from date of first dose of cobomarsen until the date of earliest documented progression or death from any cause.
Time frame: Up to approximately 36 months (estimated study duration)
Pruritis Numerical Rating Scale
Measures the patient's degree of itch related to mycosis fungoides based on an 11-point scale (from 0-10), with 0 being no itch and 10 being worst imaginable itch.
Time frame: Daily for up to 6 months, then weekly up to approximately 36 months (estimated study duration)
Skindex-29 Dermatological Survey
Measures the effects of skin disease on quality of life based on a 30-item questionnaire. The patient's responses are transformed to a linear scale from 0 to 100 and averaged to determine a subscore in three domains (Symptoms, Emotions and Functioning), as well as a total score. Lower scores indicate a lesser degree of skin disease interference with quality of life.
Time frame: Monthly, up to approximately 36 months (estimated study duration)
Pain Numerical Rating Scale
Measures the patient's intensity of pain related to mycosis fungoides based on an 11-point scale (from 0-10), with 0 being no pain and 10 being worst imaginable pain.
Time frame: Daily, for up to 6 months, then weekly up to approximately 36 months (estimated study duration)
Difference in drug tolerability by Patient Impression of Treatment Side Effects
Time frame: Weekly, up to approximately 36 months (estimated study duration)
Duration of composite global response for responding subjects
Time frame: Up to approximately 36 months (estimated study duration)
Complete response rate
Based on composite global response criteria including radiological imaging, flow cytometry, and mSWAT.
Time frame: Up to approximately 36 months (estimated study duration)
Skin disease severity based on modified Severity-weighted Assessment Tool (mSWAT)
Measures skin disease severity based on the percentage of skin within each body region with patches, plaques, or tumors. Total scores are calculated by adding the total percent for each category of lesion (patch, plaque, or tumor) and multiplying by a weighting factor. Weighted subtotals are added together to obtain the total score. Lower scores indicate a lower degree of skin disease severity.
Time frame: Monthly, up to approximately 36 months (estimated study duration)
Time to progression
Time from date of first dose of cobomarsen until the earliest date of confirmed progression.
Time frame: Up to approximately 36 months (estimated study duration)
Overall survival
Time from date of first dose of cobomarsen until the date of death from any cause.
Time frame: Up to approximately 36 months (estimated study duration)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Up to approximately 36 months (estimated study duration)
Plasma concentration of cobomarsen
Sparse pharmacokinetic samples will be collected to monitor for accumulation of cobomarsen.
Time frame: Day 1, Day 29 and monthly or every other month thereafter until End of Treatment visit, up to approximately 36 months (estimated study duration)
Number of participants with anti-drug antibody generation
Time frame: Up to approximately 36 months (estimated study duration)
Plan to share: No
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This study is terminated, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cobomarsen
miRagen Therapeutics, Inc.