NCT03837457: PRISM

PRISM: Efficacy and Safety of Cobomarsen (MRG-106) in Subjects With Mycosis Fungoides Who Have Completed the SOLAR Study

Terminated Phase 2 Last updated 19 November 2020

What this trial tests

Phase 2 trial testing Cobomarsen in Cutaneous T-Cell Lymphoma/Mycosis Fungoides in 8 participants. Terminated before completion.

Timeline

1 October 2019

Primary endpoint
24 July 2020

27 July 2020

Quick facts

Lead sponsor	miRagen Therapeutics, Inc.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	1 October 2019
Primary completion	24 July 2020
Estimated completion	27 July 2020
Sites	9 locations across Belgium, France, United States

Drugs / interventions tested

• Cobomarsen — full drug profile →

Conditions studied

• Cutaneous T-Cell Lymphoma/Mycosis Fungoides — all drugs for Cutaneous T-Cell Lymphoma/Mycosis Fungoides →

Sponsor

miRagen Therapeutics, Inc. — full company profile →

Who can join

18 and older, any sex, with Cutaneous T-Cell Lymphoma/Mycosis Fungoides. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

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

1. 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
2. The Potential for microRNA Therapeutics and Clinical Research.
   Hanna J, Hossain GS, Kocerha J. · · 2019 · cited 572× · PMID 31156715 · DOI 10.3389/fgene.2019.00478
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. RNA-Based Therapeutics: From Antisense Oligonucleotides to miRNAs.
   Bajan S, Hutvagner G. · · 2020 · cited 265× · PMID 31936122 · DOI 10.3390/cells9010137
5. Trials and Tribulations of MicroRNA Therapeutics.
   Seyhan AA. · · 2024 · cited 229× · PMID 38338746 · DOI 10.3390/ijms25031469
6. Preclinical and Clinical Development of Noncoding RNA Therapeutics for Cardiovascular Disease.
   Huang CK, Kafert-Kasting S, Thum T. · · 2020 · cited 162× · PMID 32105576 · DOI 10.1161/circresaha.119.315856
7. Reexamining assumptions about miRNA-guided gene silencing.
   Kilikevicius A, Meister G, Corey DR. · · 2022 · cited 153× · PMID 34967419 · DOI 10.1093/nar/gkab1256
8. A Comprehensive Review of Cancer MicroRNA Therapeutic Delivery Strategies.
   Forterre A, Komuro H, Aminova S, Harada M. · · 2020 · cited 150× · PMID 32660045 · DOI 10.3390/cancers12071852