Poolbeg Pharma has activated the first clinical site and begun patient recruitment for its TOPICAL study evaluating POLB 001 as a potential preventative treatment for cytokine release syndrome in multiple myeloma patients receiving immunotherapy.

The single-arm, open-label trial is investigating POLB 001 in approximately 30 patients with relapsed or refractory multiple myeloma who are being treated with the approved bispecific antibody teclistamab. The study is being conducted by Accelerating Clinical Trials and interim data are expected during summer 2026.

Cytokine release syndrome is a potentially serious inflammatory response that can occur following treatment with certain cancer immunotherapies, including bispecific antibodies. Poolbeg is assessing whether POLB 001 can help prevent the condition while patients receive teclistamab.

The TOPICAL study, short for Trial of Prevention of ImmunoCytokine Adverse events in Myeloma, follows successful site initiation and activation, allowing recruitment to begin.

Jeremy Skillington, chief executive officer of Poolbeg Pharma, said: “The successful site activation marks a significant milestone for Poolbeg and our lead programme, POLB 001.”

He added: “We look forward to receiving the first insights from the study and sharing these with prospective partners, the market, and the wider scientific community in due course.”

Paul Sherrington, chief executive officer of Accelerating Clinical Trials, said: “Site initiation and activation marks an important operational milestone for the study, as we now move forward to patient recruitment.”

He added: “We are pleased with the progress made to date and look forward to supporting efficient patient accrual recruitment and high-quality trial delivery as the study advances.”

The trial uses teclistamab, supplied by Johnson and Johnson at no cost to Poolbeg, and is expected to generate relatively rapid results because cytokine release syndrome typically develops within days or weeks of starting treatment.