BOSTON — CellCentric has begun a pivotal Phase 2 clinical trial evaluating its investigational drug inobrodib in combination with pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma.
The study, known as DOMMINO-1, is enrolling patients in the United Kingdom and the United States, with the first participant dosed at The Royal Marsden NHS Foundation Trust in London. The trial is designed to support potential regulatory approval of the therapy, which combines inobrodib 20 mg with standard doses of pomalidomide and dexamethasone, referred to as InoPd.
The company said earlier data showed the combination achieved response rates at least twice as high as alternative treatments in heavily pretreated patients who were resistant to pomalidomide and had previously received bispecific T-cell engagers or anti-BCMA therapies.
“Dosing the first patient in DOMMINO-1 marks an important milestone as we advance InoPd in registration-enabling studies,” said Naseer Qayum, M.D., Ph.D., Chief Strategy Officer and Head of R&D at CellCentric. “Inobrodib 20 mg with pom + dex has demonstrated encouraging clinical activity, including a 60% objective response rate, and a tolerability profile consistent with pom-dex alone. Patients who are refractory to pomalidomide and have progressed following bispecifics or other BCMA-directed therapies have very limited options. We believe InoPd may deliver a transformative all-oral treatment for RRMM patients and look forward to further evaluating its potential in this Phase 2 trial.”
Multiple myeloma treatment has evolved significantly over the past two decades, with patients often receiving multiple lines of therapy over time. However, many patients eventually relapse or become resistant to available treatments, highlighting the need for new approaches.
“Advances in multiple myeloma treatment, including bispecific antibodies, have improved patient outcomes. However, many people ultimately relapse or become refractory to these therapies, and new treatment options are urgently needed,” said Charlotte Pawlyn, M.D., Honorary Consultant Hematologist at The Royal Marsden NHS Foundation Trust and principal investigator for the DOMMINO-1 study. “Inobrodib represents a novel mechanism through inhibition of p300/CBP and has demonstrated the ability to be used in combination with established therapies. We look forward to further evaluating InoPd in this trial.”
DOMMINO-1 is an open-label, single-arm Phase 2 study expected to enroll about 100 adult patients across sites in the U.K. and U.S. The trial will evaluate safety and effectiveness, with the primary endpoint focused on overall response rate. Secondary measures include progression-free survival, overall survival, and duration of response.
Participants must have previously received a bispecific antibody and be refractory to at least one proteasome inhibitor, one anti-CD38 monoclonal antibody, and pomalidomide.
“InoPd appears to be a promising option in multiple myeloma treatment, not only for its tolerability and efficacy observed to date, but also for the practical benefits it may offer patients,” said Nisha Joseph, M.D., Associate Professor in the Department of Hematology and Medical Oncology at Emory University School of Medicine and principal investigator at the first U.S. trial site. “More than 70% of patients are treated in the community setting, and an all-oral regimen may facilitate and expand access for those living with this disease, as well as their caregivers and healthcare providers.”
