NCT02580552

Safety, Tolerability and Pharmacokinetics of MRG-106 in Patients With Mycosis Fungoides (MF), CLL, DLBCL or ATLL

Completed Phase 1 Last updated 23 November 2020

What this trial tests

Phase 1 trial testing Cobomarsen in Cutaneous T-cell Lymphoma (CTCL) in 66 participants. Completed in 6 October 2020.

Timeline

9 February 2016

Primary endpoint
6 October 2020

6 October 2020

Quick facts

Lead sponsor	miRagen Therapeutics, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	66
Start date	9 February 2016
Primary completion	6 October 2020
Estimated completion	6 October 2020
Sites	19 locations across United States

Drugs / interventions tested

• Cobomarsen — full drug profile →

Conditions studied

• Cutaneous T-cell Lymphoma (CTCL) — all drugs for Cutaneous T-cell Lymphoma (CTCL) →
• Mycosis Fungoides (MF) — all drugs for Mycosis Fungoides (MF) →
• Chronic Lymphocytic Leukemia (CLL) — all drugs for Chronic Lymphocytic Leukemia (CLL) →
• Diffuse Large B-Cell Lymphoma (DLBCL), ABC Subtype — all drugs for Diffuse Large B-Cell Lymphoma (DLBCL), ABC Subtype →

Sponsor

miRagen Therapeutics, Inc. — full company profile →

Who can join

18 and older, any sex, with Cutaneous T-cell Lymphoma (CTCL) or Mycosis Fungoides (MF). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Role of Non-coding RNAs in Oncology.
   Slack FJ, Chinnaiyan AM. · · 2019 · cited 1219× · PMID 31730848 · DOI 10.1016/j.cell.2019.10.017
2. Therapeutic siRNA: state of the art.
   Hu B, Zhong L, Weng Y, Peng L, et al · · 2020 · cited 991× · PMID 32561705 · DOI 10.1038/s41392-020-0207-x
3. MicroRNAs (miRNAs) and Long Non-Coding RNAs (lncRNAs) as New Tools for Cancer Therapy: First Steps from Bench to Bedside.
   Ratti M, Lampis A, Ghidini M, Salati M, et al · · 2020 · cited 403× · PMID 32451752 · DOI 10.1007/s11523-020-00717-x
4. MicroRNA: trends in clinical trials of cancer diagnosis and therapy strategies.
   Kim T, Croce CM. · · 2023 · cited 270× · PMID 37430087 · DOI 10.1038/s12276-023-01050-9
5. RNA-Based Therapeutics: From Antisense Oligonucleotides to miRNAs.
   Bajan S, Hutvagner G. · · 2020 · cited 265× · PMID 31936122 · DOI 10.3390/cells9010137
6. Antisense technology: A review.
   Crooke ST, Liang XH, Baker BF, Crooke RM. · · 2021 · cited 237× · PMID 33600796 · DOI 10.1016/j.jbc.2021.100416
7. miRNA: A Promising Therapeutic Target in Cancer.
   Menon A, Abd-Aziz N, Khalid K, Poh CL, et al · · 2022 · cited 233× · PMID 36232799 · DOI 10.3390/ijms231911502
8. Trials and Tribulations of MicroRNA Therapeutics.
   Seyhan AA. · · 2024 · cited 229× · PMID 38338746 · DOI 10.3390/ijms25031469