HEMA-MED

• Research type

  Research Study

• Full title

  A Phase I/II Open-Label, Multi-centre Study to Assess the Safety and Tolerability of Roginolisib in Combination with Ruxolitinib in Patients with Myelofibrosis (MF) who are Unresponsive to JAK inhibitors (HEMA-MED)

• IRAS ID

  1013254

• Contact name

  Tracey Hammett

• Contact email

  info@ionctura.com

• Sponsor organisation

  iOnctura

• Eudract number

  2024-515252-20

• Research summary

  Rationale for the study
  Roginolisib is a new tablet that uses the body’s own immune system to attack cancer cells. Clinical studies and experiments already done show that it stops a specific type of cell (T-reg cells) lowering the body’s own immune response.
  Objective of the study
  The main purpose of the study is to see whether a patient with a type of blood cancer (myelofibrosis) that has not responded well to standard treatment, can be safely given the standard treatment in combination with roginolisib.
  Secondary objectives of the study are:
  • to see if patients tumour will respond when roginolisib is added to the standard treatment as measured by reduction in the size of the spleen.
  • to assess any changes in the tumour cells and immune cells that infiltrate cancer tissue and in the blood
  • the pharmacokinetics (how the body interacts with the treatment)

• REC name

  London - Central Research Ethics Committee

• REC reference

  26/LO/0086

• Date of REC Opinion

  3 Mar 2026

• REC opinion

  Further Information Favourable Opinion