NX-5948 (BTK degrader) in Relapsed/Refractory B-cell Malignancies
Research type
Research Study
Full title
A Phase 1, Dose Escalation, and Cohort Expansion Study Evaluating NX-5948, a Bruton’s Tyrosine Kinase (BTK) Degrader, in Adults with Relapsed/Refractory B-cell Malignancies.
IRAS ID
1004077
Contact name
Paula O'Connor
Contact email
Sponsor organisation
Nurix Therapeutics
Eudract number
2021-003125-29
Clinicaltrials.gov Identifier
Research summary
This study aims to test NX 5948 for people with the following relapsed or refractory (not responding to treatment) B-cell
lymphomas:
• Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma
• Diffuse Large B-cell Lymphoma
• Follicular Lymphoma
• Mantle Cell Lymphoma
• Marginal Zone Lymphoma
• Waldenstrom’s Macroglobulinemia
• Primary/Secondary Central Nervous System Lymphoma
Inhibition of Bruton’s tyrosine kinase (BTK) has been shown to be safe and effective for treating several B-cell
lymphomas. However, some lymphomas develop resistance to inhibition of BTK. NX-5948 is a drug that degrades
BTK instead of inhibiting it. This study aims to evaluate if NX-5948 is safe and tolerated, identify the safest dose that
can be given, and evaluate the effect on B-cell lymphomas.
In the first part of the study (Dose Escalation, includes up to 30 patients), groups of one to six participants will be given
a low dose of the study drug. If tolerated, additional groups will receive increasing doses of the study drug (reviewed by
a Safety Review Committee).
In the second part (Cohort Expansion, includes up to 100 patients), participants in five different B-cell lymphoma
groups will receive the selected dose from the first part of the study to further evaluate side effects and what effect the
study drug has on the different types of B-cell lymphomas.
The study is expected to last about three years although individual participation will depend on whether patients have
side effects and the study doctor feels they are benefitting from treatment.
The study will have a screening, treatment, safety follow-up, and long term follow up period.
Patients’ health will be monitored for safety and continuation on study. Response assessment will be standard of care
but performed more frequently. There will be study blood samples taken and, in some patients, cerebrospinal fluid
collection (via lumbar puncture), bone marrow biopsy/ aspirates or lymph node biopsies.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
21/SC/0356
Date of REC Opinion
2 Dec 2021
REC opinion
Further Information Favourable Opinion