MEN1703 in Patients with Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma
Research type
Research Study
Full title
An Open Label, Phase 2 Clinical Trial of MEN1703 as Monotherapy and in Combination with Glofitamab in Patients with Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma (JASPIS-01)
IRAS ID
1010185
Contact name
Michał Kulesza
Contact email
Sponsor organisation
Ryvu Therapeutics SA
Research summary
This study involves an investigational drug called MEN1703 which is being tested as a possible treatment for relapsed or refractory (R/R) aggressive B-cell Non-Hodgkin Lymphoma.
MEN1703 is a drug that acts as a strong dual inhibitor, by targeting 2 key proteins in leukaemia and lymphoma cells. These proteins are called proviral integration site for Moloney murine leukaemia virus kinase (PIM) and Fms-like tyrosine kinase 3 (FLT3). PIM plays an important role in the growth and spread of lymphoma. MEN1703 works by stopping the signals from PIM and FLT3, which causes the cancer cell to stop growing and spreading.
The main purpose of this study is to see how well MEN1703 works and how tolerable and safe MEN1703 is and how it can stop lymphoma cells from growing and spreading when given alone or when combined with a targeted immunotherapy, glofitamab.
This study is divided into 4 periods: a screening period, a treatment period, an end of treatment assessment and a follow-up period. During each study period participants will have 1 or more visits with the study doctor at the study site. The screening visit will last about 2 hours, and all other visits will last about 2 hours, except the visits where participants give pharmacokinetic (PK) samples. These visits will last about 8 hours.
This is an open-label study, which means that participants, the study doctor, and any other people involved in this study will know which dose of study drug you receive.
MEN1703 has not been approved or authorised for use by any authority that regulates new medicines, including the UK MHRA.
The study will take place at approx. 36 study sites in 8 countries with about 178 people participating. The average duration of participation is expected to be approx. 2 years or as long as participants respond to the study treatment without any bad reactions. Participants will need to come to the study site at least 16 times over this period.
The study sponsor is Ryvu Therapeutics SA, Poland.REC name
North West - Haydock Research Ethics Committee
REC reference
24/NW/0281
Date of REC Opinion
1 Nov 2024
REC opinion
Further Information Favourable Opinion