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A Study of NX-5948 for Relapsed/Refractory B-cell Malignancies

This study is testing a new oral medication called NX-5948 for adults with certain types of B-cell cancers that have returned or not responded to previous treatments (relapsed/refractory). These cancers include Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Diffuse Large B Cell Lymphoma (DLBCL), Follicular Lymphoma (FL), and Mantle Cell Lymphoma (MCL). The main goals are to find a safe dose of NX-5948 and to see how well it works against these cancers. You may be able to join if you are at least 18 years old and have one of these B-cell malignancies that has relapsed or is refractory to prior therapies.

Study design
This is a first-in-human, multi-center, open-label study, meaning both you and your doctors will know you are receiving NX-5948. It plans to enroll up to 572 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track safety for up to 24 months and anti-tumor activity for up to 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05131022

A Study of NX-5948 in Adults With Relapsed/Refractory B-cell Malignancies

Recruiting
PHASE1Ages 18+InterventionalTreatment
Nurix Therapeutics, Inc.
~572 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:NX-5948

At a glance

Recruiting sites
53 of 62 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with protocol specified dose-limiting toxicities
Measured over Up to 24 months
+4 more outcomes measured

Conditions

Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma (SLL)
Diffuse Large B Cell Lymphoma (DLBCL)
Follicular Lymphoma (FL)
Mantle Cell Lymphoma (MCL)
Marginal Zone Lymphoma (MZL)
Waldenstrom Macroglobulinemia (WM)
Primary Central Nervous System Lymphoma (PCNSL)
Secondary Central Nervous System Lymphoma (SCNSL)

Explore related trials

B-Cell Malignant NeoplasmChronic Lymphocytic LeukemiaDiffuse Large B-Cell LymphomaFollicular LymphomaMantle Cell LymphomaMarginal Zone LymphomaPrimary Central Nervous System LymphomaSecondary Central Nervous System LymphomaSmall Lymphocytic LymphomaWaldenstrom Macroglobulinemia

Where it's being run

62 sites across 28 states
United Kingdom8
France7
Switzerland6
Italy5
Spain5
Netherlands4
California2
Florida2

Study leadership

  • Study Director · STUDY_DIRECTOR · Nurix Therapeutics, Inc.

Who to contact

Additional Site Contact Information
[email protected]
+1 (415) 417-3418
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥18 years
Patients in Phase 1a (Dose Escalation) must have histologically confirmed R/R CLL, SLL, DLBCL (subgroups include Richter-transformed DLBCL, germinal center B-cell type, activated B-cell type, high-grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangements, high-grade B-cell lymphomas NOS), FL, MCL, MZL (subtypes include EMZL, MALT, NMZL, SMZL), WM, or PCNSL.
Patients in Phase 1a must meet the following:
Patients in Phase 1b (Safety and Cohort Expansion) must have 1 of the following histologically documented B-cell malignancies, must meet criteria for systemic treatment, and must have received prior therapies and/or molecular features based on details described for each cohort: CLL or SLL, DLBCL, MCL, FL, MZL, WM, or PCNSL/SCNSL.
Measurable disease per response criteria specific to the malignancy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (0-2 for patients with PCNSL and secondary CNS involvement).
Adequate organ and bone marrow function

Exclusion

Known or suspected active prolymphocytic leukemia or Richter's transformation to Hodgkin's lymphoma prior to study enrollment
Prior treatment for the indication under study for anti-cancer intent that includes:
Active, uncontrolled autoimmune hemolytic anemia (except for patients enrolling in Cohort 16) or active, uncontrolled autoimmune thrombocytopenia.
Patient has any of the following within 6 months of planned start of study drug:
Bleeding diathesis, or other known risk for acute blood loss.
History of Grade ≥ 2 hemorrhage within 28 days of planned start of study drug.
Active known concurrent malignancy or malignancy other than the one under study within the past 3 years. (Exceptions include, but are not limited to, patients with more recent history of basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast may enroll if they have undergone curative therapy and have no evidence of disease).

What this trial measures

  • Number of participants with protocol specified dose-limiting toxicitiesUp to 24 months

    Phase 1a

  • To establish the maximum tolerated dose and/or recommended Phase 1b dose(s)Up to 24 months

    Phase 1a

  • To evaluate the anti-tumor activity of NX-5948 in the dose levels selected for Phase 1b safety expansion based on overall response rate (ORR) as assessed by InvestigatorUp to 3 years

    Phase 1b Part 1

  • Number of participants with treatment-emergent adverse events (TEAEs); Grade 3, 4, 5 TEAEs, serious adverse events (SAEs), TEAEs leading to study drug discontinuation, deaths due to TEAEs, and all deathsUp to 6 years

    Phase 1a / Phase 1b Part 1

  • To further evaluate the anti-tumor activity of NX-5948 in patients with CLL/SLL at the dose identified in Phase 1b Part 1 based on overall response rate (ORR) as assessed by InvestigatorUp to 3 years

    Phase 1b Part 2