Exicure has concluded subject enrolment in its ongoing randomised Phase II trial on GPC-100 (burixafor) in conjunction with propranolol and granulocyte colony-stimulating factor (G-CSF) for treating individuals with multiple myeloma who are undergoing autologous stem cell transplant (ASCT).
This multicentre, open-label, multicentre trial (NCT05561751) is aimed at evaluating the potential of a CXC chemokine receptor 4 (CXCR4) antagonist GPC-100 in enhancing cluster of differentiation 34 + (CD34+) haematopoietic stem cell mobilisation from the bone marrow into the peripheral blood for collection via leukapheresis and use in ASCT.
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Around 40 subjects will be randomly assigned to one of two treatment arms.
Patients in the trial will undergo screening within 28 days before receiving the trial drug. They are then randomised to receive either GPC-100 with propranolol or GPC-100 with propranolol and G-CSF.
The Bayesian Optimal Phase II design is being used to characterise the clinical activity and safety of GPC-100.
The administration of drugs to subjects includes a dose of 3.14mg/kg GPC-100 and 30mg of propranolol twice daily from days 1 to 8 and, if applicable, on days 9-11.
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By GlobalDataPropranolol doses are administered when patients are not on-site, with telephone follow-ups to confirm administration.
Only the group receiving GPC-100 with propranolol and G-CSF will get subcutaneous injections of G-CSF.
Subjects in this arm will be administered G-CSF injections on days 8 to 10. This administration will occur only if the participants are scheduled to undergo the optional third to fifth days of mobilisation/collection, from days 9 to 11, at the discretion of the investigator.
The collection of CD34+ stem cells via leukapheresis will commence following the administration of a morning dose of propranolol and GPC-100.
Topline outcomes from this trial are anticipated later this year.
Exicure is also planning a Phase I chemosensitisation trial in acute myeloid leukaemia (AML) subjects and is exploring GPC-100’s applications in other diseases.
Originally developed by GPCR Therapeutics, GPC-100 was incorporated into the pipeline of Exicure after the company’s acquisition in January.
