Phase 2 study of NX-5948 in Relapsed/Refractory B-cell Malignancies
Research type
Research Study
Full title
A Single-arm, Phase 2, Open-label, Multicenter Study to Evaluate NX-5948 in Adults with Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Previously Exposed to a Bruton’s Tyrosine Kinase Inhibitor (BTKi) and a B-cell Lymphoma-2 Inhibitor (BCL-2i)
IRAS ID
1011737
Contact name
Paula O'Connor
Contact email
Sponsor organisation
Nurix Therapeutics Inc
Eudract number
2025-521088-10
Clinicaltrials.gov Identifier
Research summary
This study is being run to understand if NX-5948 can help treat adults with Chronic Lymphocytic Leukaemia (CLL) or Small Lymphocytic Lymphoma (SLL) that are not or no longer responding to previous treatment.
NX-5948 is a medicine designed to target a protein called Bruton Tyrosine Kinase (BTK), which helps cancer cells grow in certain blood cancers like CLL and SLL. There are other medicines called BTK inhibitors that can slow down or stop BTK, helping patients live longer. But sometimes, these cancer cells stop responding to BTK inhibitors. NX-5948 works differently by destroying BTK. This study aims to evaluate if NX-5948 is safe and tolerated, its effect on the body (pharmacodynamics), and the way the body affects the drug (pharmacokinetics), and to evaluate its effect on CLL and SLL.
The study will have a screening period when the study doctor performs tests to determine if the requirements to participate in the study are met, a treatment period during which participants will be taking NX-5948, a safety follow-up period once treatment with NX-5948 stops, and a long term follow up period to assess overall health at 12-week intervals.
Participants will be treated with capsules of NX-5948 to be taken once daily in continuous 28-day cycles until they experience side effects that make them want to stop taking the study drug, (or their study doctor decides it is better for them to stop taking study drug), or until the disease progresses.
The study is expected to last about five years although individual participation will depend on whether patients have side effects, and the study doctor feels they are benefitting from treatment.
An Independent Data Monitoring Committee (IDMC) comprised of independent experts in relevant fields will operate autonomously from the study Sponsor and investigators to provide impartial oversight and recommendations based on study data as the study progresses.
REC name
London - London Bridge Research Ethics Committee
REC reference
25/LO/0498
Date of REC Opinion
22 Jul 2025
REC opinion
Further Information Favourable Opinion