Cobomarsen study in Mycosis Fungoides subjects completing SOLAR study

• Research type

  Research Study

• Full title

  PRISM: An Open-label, Multi-Center Extension Study to Investigate the Efficacy and Safety of Cobomarsen (MRG-106) Following Systemic Treatment in Subjects with Cutaneous T-Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Subtype, Who Have Completed the SOLAR Study

• IRAS ID

  260186

• Contact name

  Julia Scarisbrick

• Contact email

  julia.scarisbrick@uhb.nhs.uk

• Sponsor organisation

  miRagen Therapeutics, Inc.

• Eudract number

  2018-003748-22

• Clinicaltrials.gov Identifier

  NCT03837457

• Duration of Study in the UK

  2 years, 9 months, 31 days

• Research summary

  Mycosis Fungoides (MF) is the most common form of Cutaneous T-cell Lymphoma (CTCL). CTCLs occur when certain white blood cells, called T-cells, become cancerous; these cancers characteristically after the skin, causing different types of skin lesions. MF typically affect older adults (median age of diagnosis: 55 to 60 years) and may progress slowly through several stages in which skin lesions appear (patches and plaques), or are concurrent with the formation of tumours. In some late tumour-stage cases, the cancerous T-cells can spread to other organs, including lymph nodes, spleen, liver and lungs.
  Spread to other organs can occur at any stage of MF, but is most common in the tumour stage. In addition, affected individuals have an increased risk of developing another lymphoma or other type of cancer. Currently, there are no therapies that cure or prolong the survival of late-stage CTCL patients.
  In this study we are looking at a drug called cobomarsen (MRG-106), which is an antagonist of miR-155-5p. It belongs to a class of drugs called micro-RNA inhibitors and is intended to enter the cancer cells and block the activity of another molecule called miR-155-5p, which may be important for cancer cells to live and divide. This study will investigate if cobomarsen is an effective treatment for patients with MF who have shown disease progression following treatment with vorinostat in the SOLAR study (IRAS ID 251134). As a secondary purpose, we will test the safety and tolerability of cobomarsen in subjects with MF; test how cobomarsen is broken down by the human body; and test the effects of cobomarsen on the body of subjects through blood tests. The study will expect to recruit up to 60 subjects with MF (stages IB, II or III), from 60 hospitals globally (30 in Europe) and will last around 3 years.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  19/NE/0177

• Date of REC Opinion

  29 Aug 2019

• REC opinion

  Further Information Favourable Opinion