The story is a trial-activation story, not evidence that POLB 001 prevents cytokine release syndrome. Poolbeg's oncology page describes TOPICAL as the Trial of Prevention of ImmunoCytokine Adverse events in Myeloma and says interim data are expected in summer 2026. It lists the objective as investigating the safety and efficacy of POLB 001, including its ability to reduce CRS incidence in patients receiving an approved bispecific antibody.
Cytokine release syndrome, or CRS, is an inflammatory side effect that can occur after immune-based cancer therapies. Johnson & Johnson's Tecvayli medical information page says CRS has been observed in studies of teclistamab, the bispecific antibody used in the Poolbeg trial setting. That source supports the existence of the side-effect risk; it does not assess POLB 001.
Poolbeg says the trial is being run by Accelerating Clinical Trials and lists NHS sites at The Christie, The Royal Marsden, University College London Hospitals, University Hospitals Birmingham, NHS Lothian in Edinburgh and Royal Stoke University Hospital. The ISRCTN registry currently names four participating centres. The BioIndustry Association notice said first site activation had occurred, patient recruitment was under way and teclistamab was being provided by Johnson & Johnson at no cost to Poolbeg.
Table: TOPICAL trial design facts
| Field | Public record |
|---|---|
| Phase | Phase I/II |
| Design | Single-arm, open-label, uncontrolled |
| Population | About 30 relapsed or refractory multiple-myeloma patients receiving teclistamab |
| Sponsor / funder | DIDACT Foundation sponsor; Poolbeg Pharma funder |
| Chief investigator | Dr Emma Searle, The Christie |
| Primary outcome | Adverse-event and serious-adverse-event incidence |
| CRS outcome | Secondary early efficacy signal for CRS prevention |
Source: ISRCTN50499387; Poolbeg Pharma oncology page; BioIndustry Association notice, June 2026.
The ISRCTN registry identifies the study as Phase I/II, non-randomised, single-arm, open-label and uncontrolled. That means all enrolled patients receive POLB 001, with no randomised comparator group. Any apparent reduction in CRS would therefore have to be read against historical or label rates, rather than against a control arm assigned at random in the same trial.
The same registry structure makes the endpoints important. Public registry data identify safety as the primary question, including adverse events and serious adverse events, while CRS prevention is a secondary early efficacy signal. The dose-finding safety cohort starts at 150 mg twice daily, with dose-limiting-toxicity rules that can trigger de-escalation to 70 mg twice daily.
Those design limits are the central caveat. A small, open-label, uncontrolled trial can test whether the regimen is feasible and safe enough to justify further study; it cannot by itself establish a practice-changing preventive standard. It also cannot remove the need to assess CRS grade, timing, rescue treatment, teclistamab dosing context and whether any signal is large enough to matter clinically.