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Taking people in FrancePhase 1

Tests NX-5948 in adults with returned or hard-to-treat B-cell cancers

Tests NX-5948 in adults with B-cell cancers that returned or did not respond.

Key facts

Who runs it
Nurix Therapeutics, Inc.
Where
Angers, Bobigny, Nantes, Pessac, Poitiers, Saint-Cloud, and Vandœuvre-lès-Nancy, FranceSee the 7 sitesAlso in 7 other countries, 55 sites
Registry title
A Study of NX-5948 in Adults With Relapsed/Refractory B-cell Malignancies
Status
Recruiting
Phase
Phase 1
People taking part
572 people, planned
Started
13 Apr 2022
Expected to end
Jan 2028
Type of study
Interventional, 19 groups
Treatments tested
  • NX-5948
Record updated
2 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults whose B-cell cancer (such as CLL, SLL, DLBCL, FL, MCL, MZL, WM or CNS lymphoma) has come back or stopped responding to earlier treatment.

Age
18 years or older
Sex
All sexes can join
Disease stage
Relapsed or refractory B-cell cancer confirmed by tissue examination, with measurable disease. In the dose-escalation part: CLL, SLL, DLBCL, FL, MCL, MZL, WM or PCNSL. In the expansion part: CLL or SLL, DLBCL, MCL, FL, MZL, WM or PCNSL/SCNSL, with a need for systemic treatment.
Earlier treatment
In the dose-escalation part, at least 2 earlier lines of therapy for cancers other than PCNSL, with no other therapy known to help. For PCNSL, at least 1 earlier line. Cannot join if previously treated with a BTK degrader, or if recent treatments are too close to the start, such as radiotherapy or chemotherapy within 2 weeks, antibody therapy within 4 weeks, or a stem cell transplant within 100 days.

Main reasons for not taking part

  • Active prolymphocytic leukemia, or Richter's transformation to Hodgkin's lymphoma
  • Active uncontrolled autoimmune hemolytic anemia or autoimmune thrombocytopenia (with an exception for Cohort 16)
  • Heart attack, unstable angina, serious heart rhythm problems, heart failure, stroke or blood clots within the last 6 months
  • Bleeding disorder, or a grade 2 or higher bleed within 28 days
  • Another active cancer, or a different cancer within the past 3 years (some skin and early cancers allowed)

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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:; o For non-PCNSL indications, received at least 2 prior lines of therapy and have no other available therapies known to provide clinical benefit. For PCNSL, received at least 1 prior line of therapy
  • 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

Who cannot take part

  • 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:; Radiotherapy within 2 weeks of planned start of study drug (excluding limited palliative radiation); Prior systemic chemotherapy within 2 weeks of planned start of study drug; Prior monoclonal antibody therapy within 4 weeks of planned start of study drug, except for patients enrolling in Cohort 16 (CLL with secondary wAIHA) where a 16-week washout period is required; Prior small molecule therapy within 2 weeks or 5 half-lives (whichever is shorter) of planned start of study drug; Autologous or allogeneic stem cell transplant within 100 days prior to planned start of study drug; Chimeric antigen receptor (CAR) T-cell therapy within 100 days prior to start of study drug (within 60 days prior to start of study drug for Phase 1b); Use of systemic corticosteroids outside of dosing limits described below and within 7 days prior to initiation of study treatment excepting those used as prophylaxis for radio diagnostic contrast. Patients with PCNSL/SCNSL: no greater than 40 mg/day prednisone, or equivalent. Patients with PCNSL/SCNSL using greater than 20 mg/day prednisone, or equivalent, must be clinically stable at that dose for 7 days. All other diagnoses: no greater than 20 mg/day prednisone or equivalent; Use of systemic immunosuppressive drugs other than systemic corticosteroids for any medical condition within 60 days prior to first dose of study drug; Previously treated with a BTK degrader
  • 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)
  • 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:; Myocardial infarction, unstable angina, unstable symptomatic ischemic heart disease, or placement of a coronary arterial stent; Uncontrolled atrial fibrillation or other clinically significant arrhythmias, conduction abnormalities, or New York Heart Association (NYHA) class III or IV heart failure; Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), stroke, or intracranial hemorrhage; Any other significant cardiac condition (e.g., pericardial effusion, restrictive cardiomyopathy, severe untreated valvular stenosis, severe congenital heart disease, or persistent uncontrolled hypertension defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg despite optimal medical management)
  • Bleeding diathesis, or other known risk for acute blood loss
  • History of Grade ≥ 2 hemorrhage within 28 days of planned start of study drug

Where in France

Also in 7 other countries, 55 sites

  • CHU AngersAngers, FranceTaking people
  • Hopital AvicenneBobigny, FranceTaking people
  • CHU de NantesNantes, FranceTaking people
  • CHU BordeauxPessac, FranceTaking people
  • CHU de PoitiersPoitiers, FranceTaking people
  • Institut Curie -site Saint-CloudSaint-Cloud, FranceTaking people
  • CHRU de NancyVandœuvre-lès-Nancy, FranceTaking people

About the trial

What the trial wants to find out

This is a first-in-human Phase 1a/1b multicenter, open-label study designed to evaluate the safety and anti-cancer activity of NX-5948 in patients with advanced B-cell malignancies.

The 19 groups in the trial

  • Phase 1a Dose EscalationTreatment being tested

    Multiple dose levels of NX-5948 to be evaluated; determination of Maximum Tolerated Dose/Phase 1b recommended dose(s)

    Treatment: NX-5948

  • Phase 1b Part 1 Cohort 1 in CLL or SLL with prior BTKi and BCL2iTreatment being tested

    CLL or SLL with prior exposure to both a Bruton's tyrosine kinase inhibitor (BTKi) and BCL-2 inhibitor, unless previously deemed ineligible for a BCL-2i. Patients enrolled in CLL/SLL arm will be randomized to one of two dose levels.

    Treatment: NX-5948

  • Phase 1b Part 1 Cohort 2 in CLL/SLL with non-C481S BTK mutationsTreatment being tested

    Prior exposure to both BTKi and BCL-2i (unless deemed ineligible for BCL-2i by Investigator at the time of study enrollment) and documented BTK mutation other than C481S within 6 months prior to study entry

    Treatment: NX-5948

  • Phase 1b Part 1 Cohort 3 in CLL/SLL with prior non-covalent BTKiTreatment being tested

    CLL/SLL with prior exposure to ncBTKi and are BCL-2i naïve.

    Treatment: NX-5948

  • Phase 1b Part 1 Cohort 4 in CLL/SLL with TP53 or 17p deletion, 2L, prior BTKiTreatment being tested

    Patients with documented TP53 mutation or 17p deletion and 1 prior line of therapy that included a BTKi and are BCL-2i naïve.

    Treatment: NX-5948

  • Phase 1b Part 1 Cohort 5 in CLL/SLL with 2L+, prior BTKiTreatment being tested

    Patients with at least 1 prior line of therapy that included a BTKi and are BCL-2i naïve.

    Treatment: NX-5948

  • Phase 1b Part 1 Cohort 6 in MCLTreatment being tested

    Non-blastoid MCL with prior exposure to a BTKi and an anti-CD20 monoclonal antibody (mAb)-based chemoimmunotherapy regimen

    Treatment: NX-5948

  • Phase 1b Part 1 Cohort 7 in MZLTreatment being tested

    MZL (EMZL, MALT, NMZL, SMZL) with prior exposure to an anti-CD20 mAb-based chemo-immunotherapy regimen and an additional line of therapy

    Treatment: NX-5948

  • Phase 1b Part 1 Cohort 8 in WM (3L+)Treatment being tested

    WM with prior exposure to a BTKi and at least an additional line of therapy

    Treatment: NX-5948

  • Phase 1b Part 1 Cohort 9 in WM (2L)Treatment being tested

    WM following upfront therapy with a BTKi

    Treatment: NX-5948

  • Phase 1b Part 1 Cohort 10 in DLBCLTreatment being tested

    DLBCL which transformed from indolent lymphoma or Richters transformation with prior exposure to an anthracycline (unless previously deemed ineligible to receive), an anti-CD20 mAb-based chemoimmunotherapy regimen, and an additional line of therapy

    Treatment: NX-5948

  • Phase 1b Part 1 Cohort 11 in FLTreatment being tested

    FL (grade 1-3a) with prior exposure to an anti-CD20 mAb-based chemoimmunotherapy regimen and an additional line of therapy

    Treatment: NX-5948

  • Phase 1b Part 1 Cohort 12 in PCNSL/SCNSLTreatment being tested

    PCNSL following at least 1 prior line of therapy that included a BTKi (2L+) or following 2 or more prior lines of therapy (3L+), or SCNSL patients meeting criteria for a non-CLL/SLL cohort enrolling that disease with secondary CNS involvement of lymphoma

    Treatment: NX-5948

  • Phase 1b Part 1 Cohort 13 in PCNSLTreatment being tested

    PCNSL following upfront therapy and with no prior exposure to a BTKi (2L).

    Treatment: NX-5948

  • Phase 1b Part 2 in CLL or SLL with prior BTKi and BCL-2iTreatment being tested

    CLL or SLL with prior exposure to both a Bruton's tyrosine kinase inhibitor (BTKi) and BCL-2 inhibitor

    Treatment: NX-5948

  • Phase 1b Part 1 Cohort 14 in first-line WMTreatment being tested

    Treatment-naïve WM deemed unfit for chemoimmunotherapy

    Treatment: NX-5948

  • Phase 1b Part 1 Cohort 15 in BTKi-naive CLL/SLLTreatment being tested

    First-line (1L) or second-line+ (2L)+ CLL/SLL with no prior exposure to a BTKi

    Treatment: NX-5948

  • Phase 1b Part 1 Cohort 16 in CLL/SLL with secondary warm autoimmune hemolytic anemia (wAIHA)Treatment being tested

    BTKi-exposed R/R CLL or SLL with secondary wAIHA

    Treatment: NX-5948

  • Phase 1b Part 1 Cohort 17 in CLL/SLL with CNS involvementTreatment being tested

    BTKi-exposed R/R CLL or SLL with CNS involvement

    Treatment: NX-5948

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official 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
Plain-language title
Tests NX-5948 in adults with returned or hard-to-treat B-cell cancersGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
2 July 2026