Tests NX-5948 in adults with chronic lymphocytic leukemia or small lymphocytic lymphoma

Trial details

Who runs it

Nurix Therapeutics, Inc.

Trial code

NCT07221500

Record updated

3 November 2026

Original description

This is a study for patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received treatment with a BTK inhibitor (covalent and non-covalent) and a BCL-2 inhibitor. The main purpose of this study is to test if NX-5948 (bexobrutideg) works to treat patients with CLL/SLL. Participation could last up to 5 years, and possibly longer, if the disease does not progress.Read full original descriptionShow less

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)

This is a study for patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received treatment with a BTK inhibitor (covalent and non-covalent) and a BCL-2 inhibitor. The main purpose of this study is to test if NX-5948 (bexobrutideg) works to treat patients with CLL/SLL. Participation could last up to 5 years, and possibly longer, if the disease does not progress.

Inclusion: Age: ≥ 18 years; Confirmed relapsed/refractory CLL/SLL that meets iwCLL criteria for diagnosis and systemic treatment; Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; Must have received a covalent BTK inhibitor (BTKi), a non-covalent BTKi, and a BCL-2 inhibitor either in separate lines of therapy or in combination; a line of therapy is considered 2 or more consecutive cycles of a systemic anti-CLL/SLL regimen; Participants with SLL must have measurable disease by radiographic assessment; Adequate organ and bone marrow function; Must sign an informed consent form indicating that he or she understands the purpose of the procedures required for the study and is willing to participate.

Exclusion: Investigational agent or anticancer therapy within 5 half-lives or 14 days (whichever is shorter) before planned start of study drug; Antibody therapy must stop at least 4 weeks before the first dose of study drug; No other systemic anticancer therapy is allowed at the same time as this study; exception: continuation of hormonal therapy for breast and prostate cancer is allowed, if they are not on the list of prohibited concomitant medications in this study; Palliative limited-field radiotherapy within 7 days of the first dose of study or broad field radiotherapy within 28 days of first dose of study drug; Use of systemic corticosteroids >20 mg/day prednisone or equivalent within the 7 days before start of study drug except for those used as premedication for radio diagnostic contrast; Use of systemic immunosuppressive drugs other than systemic corticosteroids within 60 days before the first dose of study drug; Previously treated with a BTK degrader; Previous chimeric antigen receptor (CAR) T-cell therapy or allogeneic or autologous hematopoietic cell transplant within the past 90 days prior to enrollment; Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), stroke, or intracranial hemorrhage within 6 months of planned start of study drug; Note: Other Inclusion/Exclusion criteria may apply as defined in the protocol; Known or suspected prolymphocytic leukemia or Richter's transformation before entering study.

ClinicalTrials.gov NCT07221500