New drug takes aim at Hard-to-Treat blood cancers
NCT ID NCT05131022
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This early-phase study tests a new drug called NX-5948 in adults with advanced B-cell blood cancers (like certain leukemias and lymphomas) that have not responded to other treatments. The drug works by breaking down a protein (BTK) that helps these cancer cells grow. The main goals are to find a safe dose and see if the drug can shrink tumors.
Why investors are watching
Nurix Therapeutics is testing NX-5948, a drug that degrades BTK, a protein that helps certain blood cancers grow, in people whose cancers have returned or stopped responding to treatment. This is the first human study of the drug, and for a small company, early signs of safety and tumor shrinkage in a phase 1 trial can determine whether the drug moves forward. A clear signal of activity in this 572-person study would validate the company's main research approach.
If it works: If NX-5948 shows acceptable safety and shrinks tumors in a meaningful share of patients, Nurix could advance the drug to later-stage trials and attract partnership interest. That outcome would support the company's value as a developer of targeted cancer therapies.
If it fails: Phase 1 trials often fail because the drug proves too toxic or shows little benefit, and Nurix has no other late-stage products to fall back on. A disappointing readout or a delay in enrollment could hurt the company's prospects and its ability to fund future work.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 572 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2022
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
53 sites in 8 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
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Study contacts
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Contact
Email: •••••@•••••
Locations
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ASST Spedali Civili Brescia
WITHDRAWNBrescia, 25123, Italy
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AidPort sp. Zo.o
RECRUITINGSkórzewo, Greater Poland Voivodeship, 60-185, Poland
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CHRU de Nancy
RECRUITINGVandœuvre-lès-Nancy, 54500, France
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CHU Angers
RECRUITINGAngers, 49933, France
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CHU Bordeaux
RECRUITINGPessac, 33604, France
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CHU de Nantes
RECRUITINGNantes, 44093, France
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CHU de Poitiers
RECRUITINGPoitiers, 86021, France
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Cayuga Medical Center
WITHDRAWNIthaca, New York, 14850, United States
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City of Hope
RECRUITINGDuarte, California, 91010, United States
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Clatterbridge Cancer Center NHS Foundation Trust
RECRUITINGLiverpool, L7 8YA, United Kingdom
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Cleveland Clinic
RECRUITINGCleveland, Ohio, 44195, United States
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Colorado Blood Cancer Institute
RECRUITINGDenver, Colorado, 80218, United States
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Duke University Medical Center
RECRUITINGDurham, North Carolina, 27705, United States
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Erasmus MC
RECRUITINGRotterdam, 3015 GD, Netherlands
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Florida Cancer Specialists
RECRUITINGSarasota, Florida, 34232, United States
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Fondazione Policlinico Universitario A. Gemelli IRCCS
RECRUITINGRome, 00168, Italy
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Hospital Clínic de Barcelona
RECRUITINGBarcelona, 08036, Spain
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Hospital Fundación Jimenez Díaz - START Madrid
RECRUITINGMadrid, 28040, Spain
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Hospital Ramón y Cajal
RECRUITINGMadrid, 28034, Spain
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Hospital Universitari Vall d'Hebron
RECRUITINGBarcelona, 08035, Spain
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Hospital Universitario de Cabuenes
RECRUITINGGijón, 33203, Spain
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Huntsman Cancer Institute
WITHDRAWNSalt Lake City, Utah, 84112, United States
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Hôpital Avicenne
RECRUITINGBobigny, 93009, France
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Hôpitaux Universitaires de Genève
WITHDRAWNGeneva, 1205, Switzerland
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IRCCS - AOU di Bologna
WITHDRAWNBologna, 40138, Italy
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IRCCS Ospedale San Raffaele
RECRUITINGMilan, 20132, Italy
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IRCCS Ospedale San Raffaele - Università Vita-Salute San Raffaele di Milano
RECRUITINGMilan, 20132, Italy
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Inselspital - Universitatsklinik Bern
WITHDRAWNBern, 3010, Switzerland
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Institut Curie-Site Saint-Cloud
RECRUITINGSaint-Cloud, 92210, France
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Istituto Oncologico della Svizzera Italiana
RECRUITINGBellinzona, Switzerland
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Kantonsspital St.Gallen
WITHDRAWNSankt Gallen, 9007, Switzerland
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MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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Medical College of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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Medical University of Lublin
RECRUITINGLublin, 20-090, Poland
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Memorial Sloan Kettering Cancer Center
ACTIVE_NOT_RECRUITINGNew York, New York, 10065, United States
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National Institute of Health
RECRUITINGBethesda, Maryland, 20814, United States
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National Institute of Oncology Warszawa
RECRUITINGWarsaw, Masovian Voivodeship, 02-781, Poland
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Northwestern University
RECRUITINGChicago, Illinois, 60611, United States
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Oxford University Hospitals NHS Foundation Trust
RECRUITINGOxford, OX3 7LE, United Kingdom
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Pratia MCM
RECRUITINGKrakow, Lesser Poland Voivodeship, 30-272, Poland
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Pratia MTZ
RECRUITINGWarsaw, Masovian Voivodeship, 02-172, Poland
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Pratia Onkologia Katowice
RECRUITINGKatowice, Silesian Voivodeship, 40-519, Poland
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Radboud University Medical Center
RECRUITINGNijmegen, 6525 GA, Netherlands
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Royal Marsden NHS Foundation Trust
RECRUITINGSutton, SM2 5PT, United Kingdom
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Sarah Cannon Research Institute UK
RECRUITINGLondon, W1G 6AD, United Kingdom
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St. Bartholomew's Hospital, Barts NHS Trust
RECRUITINGLondon, EC1A 7BE, United Kingdom
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St. James Hospital
RECRUITINGLeeds, LS9 7TF, United Kingdom
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The Beatson WOS Cancer Center
RECRUITINGGlasgow, Scotland, G12 0YN, United Kingdom
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The Christie NHS Foundation Trust
RECRUITINGManchester, Manchester, M20 4BX, United Kingdom
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University Clinical Hostpital in Wroclaw
RECRUITINGWroclaw, Lower Silesian Voivodeship, 50-367, Poland
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University Hospital Southampton NHS Foundation Trust
RECRUITINGSouthampton, SO16 6YD, United Kingdom
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University Hospital Zurich
RECRUITINGZurich, 8091, Switzerland
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University Hospitals Plymouth NHS Trust
RECRUITINGPlymouth, PL6 8DH, United Kingdom
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University Medical Center Groningen
WITHDRAWNGroningen, 9713 GZ, Netherlands
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University Medical Center Utrecht
RECRUITINGUtrecht, 3584 CX, Netherlands
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University of California, San Francisco
RECRUITINGSan Francisco, California, 94143, United States
Contact Email: •••••@•••••
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University of Cincinnati Medical Center
RECRUITINGCincinnati, Ohio, 45219, United States
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University of Miami
RECRUITINGMiami, Florida, 33136, United States
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University of Pennsylvania, Abramson Cancer Center
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Universitätsspital Basel
RECRUITINGBasel, 4031, Switzerland
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Winship Cancer Institute of Emory University
RECRUITINGAtlanta, Georgia, 30322, United States
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Yale Cancer Center
RECRUITINGNew Haven, Connecticut, 06510, United States
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Other studies related to the condition(s) this trial covers.
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