Trial of Prevention of ImmunoCytokine Adverse events in MyeLoma (TOPICAL)
Research type
Research Study
Full title
A non—randomised, single arm, multi-centre, open label Phase I/II trial to investigate novel cytokine release syndrome prevention in patients with multiple myeloma eligible to receive the bispecific t-cell engager antibody, teclistamab, within its licensed indication
IRAS ID
1012909
Contact name
Paul Robinson
Contact email
Sponsor organisation
DIDACT Foundation
ISRCTN Number
ISRCTN50499387
Research summary
This study is testing a new way to reduce the risk of a common side effect called cytokine release syndrome (CRS) in people with multiple myeloma whose disease has come back or stopped responding to treatment and who are starting treatment with a medicine called teclistamab. Teclistamab is a type of immunotherapy that helps the body’s immune system fight myeloma. While it can be effective, it can also cause CRS, a reaction where the immune system becomes overactive and causes symptoms like fever, low blood pressure, or breathing problems. The trial will test whether a new oral drug called POLB 001 can help prevent CRS when given before and during the early stages of teclistamab treatment.
What will happen in the study?
- Around 30 patients will take part across 6 hospitals in the UK.
- All participants will receive POLB 001for 14 days, starting just before their first dose of teclistamab.
- After that, they will continue teclistamab on the trial for 2 cycles (8 weeks) before seamlessly moving over to NHS supplied teclistamab which can be continued for long as it remains effective. Patients will be in this study for around 3 months.
- Patients will be closely monitored for side effects and signs of CRS.
- Some patients may receive a lower dose of POLB 001 if early results suggest the higher dose causes side effects.The main goal is to see if POLB 001 is safe and whether it can prevent CRS or make it less severe. Researchers will also look at how well teclistamab works and how POLB 001 moves through the body (for example absorption and metabolism).
What are the risks and benefits?
- POLB 001 has been found well tolerated in healthy volunteer studies, with no serious side effects reported. POLB 001 is a new drug, so there may be unknown side effects.
- Patients will be monitored closely, and treatments will be given to manage CRS if it occurs.
- The study may help improve the safety of teclistamab treatment for future patients.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
26/WM/0017
Date of REC Opinion
20 Feb 2026
REC opinion
Further Information Favourable Opinion