In short
GSK5926371 is an investigational medicine being studied in a Phase 1 clinical trial for adults with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL). The trial, registered in the EU Clinical Trials Information System as 2025-524915-36-00, is authorised and plans to enrol 49 participants. The main goal is to evaluate the safety and tolerability of GSK5926371 given by subcutaneous injection and to establish a recommended dose for further studies.
Key points
- GSK5926371 is an investigational substance with no marketing authorisation in these records.
- The single registered trial is a Phase 1 study in adults with relapsed or refractory B-cell non-Hodgkin lymphoma.
- The trial is authorised and plans to enrol 49 participants.
- GSK5926371 is given by subcutaneous injection.
- The primary outcomes are dose-limiting toxicities and adverse events by severity.
- The trial aims to establish a recommended dose for expansion or a recommended Phase 2 dose.
What is GSK5926371?
GSK5926371 is an investigational substance being developed by GSK for the treatment of blood cancers. The full name GSK5926371 is a development code, and no trade name has been assigned in the registry records. Based on the trial record, GSK5926371 is being studied in oncology, specifically in B-cell non-Hodgkin lymphoma. The substance is not yet authorised as a medicine; it is still in the early stages of clinical research.
How does GSK5926371 work?
The registry record does not describe the mechanism of action of GSK5926371. The trial is designed to evaluate safety and clinical activity in relapsed or refractory B-NHL, a form of lymphoma that has returned after treatment or has not responded to previous therapy. Because this is a Phase 1 trial, the primary focus is on establishing the safety profile and determining a dose that can be taken forward into later studies.
Which conditions is GSK5926371 studied for?
The only condition listed in the trial record is:
- Non-Hodgkin lymphoma (B-NHL) — a cancer of the lymphatic system affecting B cells, a type of white blood cell. In this trial, participants have relapsed or refractory disease, meaning the lymphoma has come back after treatment or has not responded to prior therapy.
How is GSK5926371 given?
GSK5926371 is administered by subcutaneous injection, which means it is injected under the skin. The trial record does not provide further details on the dosing schedule or the specific formulation used.
What do the clinical trials show?
There is one registered clinical trial for GSK5926371. It is a Phase 1, interventional study that is currently authorised and plans to enrol 49 adult participants with relapsed or refractory B-cell non-Hodgkin lymphoma.
The primary outcomes measured in this trial are:
- The number of participants with dose-limiting toxicities (DLTs) — side effects severe enough to prevent increasing the dose.
- The number of participants with adverse events (AEs) or serious adverse events (SAEs), graded by severity.
The stated objective of the trial is to evaluate the safety and tolerability of GSK5926371 and to establish a recommended dose for expansion (RDE) and/or a recommended Phase 2 dose (RP2D). No efficacy results are yet available, as the trial has not reported outcomes.
What side effects are known?
No side effect data are available for GSK5926371. The trial is designed specifically to collect information on adverse events and dose-limiting toxicities, but no results have been published in the registry record.