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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02580552.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Name Not Available
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.
Lead OrganizationmiRagen Therapeutics, Inc.
