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Looking for participantsPhase1

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

Sponsor: Nurix Therapeutics, Inc.

NCT ID: NCT05131022

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
NX-5948 (drug)
How long the study runs
Study runs about 69 months (dates as stated)
About the drug or intervention
NX-5948 — drug: Oral NX-5948
Patient visit burden
Not specified by the sponsor

In plain English

This study is testing a new drug called NX-5948 in adults whose B-cell blood cancers (such as chronic lymphocytic leukaemia and several types of lymphoma) have come back or not responded to treatment. It is run by Nurix Therapeutics, Inc.

Who can take part

  • Adults aged 18 or over
  • Have a confirmed B-cell cancer from the list, such as chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL), diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), Waldenström macroglobulinaemia (WM), or primary central nervous system lymphoma (PCNSL)
  • In the first part of the study (Phase 1a): for most cancers, at least 2 previous treatments with no other helpful options left; for PCNSL, at least 1 previous treatment
  • In the second part (Phase 1b): have one of the listed B-cell cancers, need systemic treatment, and meet the previous-treatment rules for your group
  • Cancer that can be measured
  • Able to carry out light activity (performance status of 0 or 1; 0 to 2 for people with PCNSL or secondary central nervous system involvement)
  • Good working organs and bone marrow

Who may not be able to

  • Known or suspected prolymphocytic leukaemia, or Richter's transformation to Hodgkin's lymphoma before joining
  • Recent cancer treatments too close to the start of the study drug (for example, chemotherapy or radiotherapy within 2 weeks, antibody therapy within 4 weeks, or a stem cell transplant or CAR T-cell therapy within 100 days)
  • More than set limits of steroid medicine, or other immune-suppressing drugs within 60 days
  • Previous treatment with a BTK degrader (a type of drug)
  • Active, uncontrolled autoimmune haemolytic anaemia (except in one study group) or active autoimmune thrombocytopenia (low platelets)
  • Certain heart or blood vessel problems within the last 6 months, such as heart attack, unstable angina, uncontrolled irregular heartbeat, blood clots, stroke, or bleeding in the brain
  • A bleeding condition or risk of sudden blood loss, or bleeding of Grade 2 or worse within 28 days
  • Another cancer now, or within the past 3 years, apart from some treated early skin, bladder, cervix or breast cancers with no signs of disease

What taking part involves

  • • Taking the study drug NX-5948 — details of how it is given are not stated — ask the trial team

Time commitment: Not stated — ask the trial team about how long the study lasts, how often visits happen, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
572
Started
2022-04-13
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for chronic lymphocytic leukemia (cll)
  • • Phase1 - 572 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with chronic lymphocytic leukemia (cll)

Where?

  • • Manchester - The Christie NHS Foundation Trust
  • • Glasgow - The Beatson WOS Cancer Center
  • • Leeds - St. James Hospital
  • • Liverpool - Clatterbridge Cancer Center NHS Foundation Trust
  • • +6 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

Phase 1a is a dose escalation to evaluate the safety and tolerability of NX-5948 in adult patients with relapsed/refractory (R/R) B cell malignancies who have received at least 2 prior lines of therapy, or at least 1 prior line of therapy for Primary Central Nervous System Lymphoma (PCNSL), and for whom no other therapies are known to provide clinical benefit. Indications include: Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Diffuse Large B-cell Lymphoma (DLBCL), Mantle Cell Lymphoma (MCL), Waldenstrom Macroglobulinemia (WM), Marginal Zone Lymphoma (MZL), Follicular Lymphoma (FL), Primary Central Nervous System Lymphoma (PCNSL) or any of the above indications with disease in the central nervous system or Secondary Central Nervous System Lymphoma (SCNSL). Phase 1b Part 1, called safety expansion, investigates the safety and anti-tumor activity of NX-5948 at the dose(s) selected in Phase 1a in up to 17 expansion cohorts of patients with histologically confirmed B-cell malignancy indications who have received specified prior therapies based on indication: * CLL or SLL (patients may be randomized to one of two dose levels investigated for CLL/SLL until an optimal dose is selected) * MCL * MZL * WM * DLBCL * FL * PCNSL/SCNSL Phase 1b Part 2, called cohort expansion, will further investigate the anti-tumor activity of NX-5948 at the dose(s) selected in Phase 1b par 1 in one additional expansion arm of CLL/SLL patients.

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)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ of therapy

What the study is looking for

  • ✓Age ≥18 years
  • ✓Patients in Phase 1a must meet the following:
  • ✓o For non-PCNSL indications, received at least 2 previous treatments and have no other available therapies known...
  • ✓cancer that can be measured on scans per response criteria specific to the cancer.
  • ✓activity scale (ECOG) performance status of 0 or 1 (0-2 for patients with PCNSL and secondary...

Who cannot take part

  • ✗Known or suspected active prolymphocytic leukemia or Richter's transformation to Hodgkin's lymphoma prior to study...
  • ✗Prior treatment for the indication under study for anti-cancer intent that includes:
  • ✗Radiotherapy within 2 weeks of planned start of the study treatment (excluding limited palliative radiation).
  • ✗Prior systemic drug treatment within 2 weeks of planned start of the study treatment.
  • ✗Prior monoclonal antibody therapy within 4 weeks of planned start of the study treatment, except for patients enrolling in...
See the full criteria
Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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: 1. Radiotherapy within 2 weeks of planned start of study drug (excluding limited palliative radiation). 2. Prior systemic chemotherapy within 2 weeks of planned start of study drug. 3. 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. 4. Prior small molecule therapy within 2 weeks or 5 half-lives (whichever is shorter) of planned start of study drug. 5. Autologous or allogeneic stem cell transplant within 100 days prior to planned start of study drug. 6. 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). 7. 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. 8. Use of systemic immunosuppressive drugs other than systemic corticosteroids for any medical condition within 60 days prior to first dose of study drug 9. Previously treated with a BTK degrader * 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: 1. Myocardial infarction, unstable angina, unstable symptomatic ischemic heart disease, or placement of a coronary arterial stent 2. Uncontrolled atrial fibrillation or other clinically significant arrhythmias, conduction abnormalities, or New York Heart Association (NYHA) class III or IV heart failure 3. Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), stroke, or intracranial hemorrhage 4. 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. * 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).

Where Is This Study? (10 UK sites)

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

The Beatson WOS Cancer Center

Glasgow G12 0YN, United Kingdom

Recruiting

St. James Hospital

Leeds LS9 7TF, United Kingdom

Recruiting

Clatterbridge Cancer Center NHS Foundation Trust

Liverpool L7 8YA, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Maria Maguire

maria.maguire2@nhs.net0151 556 5321

St. Bartholomew's Hospital, Barts NHS Trust

London EC1A 7BE, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mays Jawad

research.governance@qmul.ac.uk020 7882 6826

Sarah Cannon Research Institute UK

London W1G 6AD, United Kingdom

Recruiting

Oxford University Hospitals NHS Foundation Trust

Oxford OX3 7LE, United Kingdom

Recruiting
Hospital R&D contact (matched)

Shahista Hussain

ouhtma@ouh.nhs.uk---

University Hospitals Plymouth NHS Trust

Plymouth PL6 8DH, United Kingdom

Recruiting
Hospital R&D contact (matched)

R&D Manager

plh-tr.RD-office@nhs.net01752 431776

University Hospital Southampton NHS Foundation Trust

Southampton SO16 6YD, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

Royal Marsden NHS Foundation Trust

Sutton SM2 5PT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

How to Get in Touch

Additional Site Contact Information

Sponsor contact

CONTACT

+1 (415) 417-3418 clinicaltrials@nurixtx.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-06