> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-nx-5948-in-adults-with-relapsed-refractory-b-cell-e6f19e49-bdcf-4d6f-9c0f-10ecf9076e2a > Record changed: 2026-10-13 # A Study of NX-5948 in Adults With Relapsed/Refractory B-cell Malignancies NCT05131022 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) Participants 572 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) Lead sponsor Nurix Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) Start date 2022-04-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) Number of sites 62 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) **Short title** A Study of NX-5948 in Adults With Relapsed/Refractory B-cell Malignancies Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) ## Dates **Completion date** 2028-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) **First posted** 2021-11-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) **Registry last updated** 2026-07-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) **Primary completion date** 2027-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) **Start date** 2022-04-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) ## Size and sites **Participants** 572 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) **Planned participants** 572 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) **Protocol amendments** 9 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) **Number of sites** 62 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) **Lead sponsor** Nurix Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) ## Identifiers **Registry ID** NCT05131022 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) **ClinicalTrials.gov ID** NCT05131022 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) ## Outcomes ### Primary outcomes 1. Number of participants with protocol specified dose-limiting toxicities Timeframe: Up to 24 months Phase 1a 2. To establish the maximum tolerated dose and/or recommended Phase 1b dose(s) Timeframe: Up to 24 months Phase 1a 3. 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 Investigator Timeframe: Up to 3 years Phase 1b Part 1 4. 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 deaths Timeframe: Up to 6 years Phase 1a / Phase 1b Part 1 5. 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 Investigator Timeframe: Up to 3 years Phase 1b Part 2 ### Secondary outcomes 1. Pharmacokinetic (PK) profile of NX-5948: Maximum Serum Concentration Timeframe: Up to 6 years Phase 1a / Phase 1b Part 1 and Part 2 - Sampling following the first dose, pre- and post-dose at selected cycles and at the end of treatment 2. Pharmacodynamic (PD) profile of NX-5948: Changes from baseline of BTK levels in B-cells Timeframe: Up to 6 years Phase 1a / Phase 1b Part 1 and Part 2 - Sampling at screening, following the first dose, pre and post-dose at selected cycles and at the end of treatment 3. Complete response (CR) rate / CR with incomplete marrow recovery as assessed by the Investigator Timeframe: Up to 6 years Phase 1a / Phase 1b Part 1 and Part 2 4. Duration of response (DOR) as assessed by the Investigator Timeframe: Up to 6 years Phase 1a / Phase 1b Part 1 and Part 2 5. Progression-free survival (PFS) as assessed by the Investigator Timeframe: Up to 6 years Phase 1a / Phase 1b Part 1 and Part 2 6. Time to next therapy Timeframe: Up to 6 years Phase 1a / Phase 1b Part 1 and Part 2 7. 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 deaths Timeframe: Up to 3 years Phase 1b Part 2 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No 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). Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) ## Sites - City of HopeDuarte, United StatesRecruiting - University of California, San FranciscoSan Francisco, United StatesRecruiting - Colorado Blood Cancer InstituteDenver, United StatesRecruiting - Yale Cancer CenterNew Haven, United StatesRecruiting - University of MiamiMiami, United StatesRecruiting - Florida Cancer SpecialistsSarasota, United StatesRecruiting - Winship Cancer Institute of Emory UniversityAtlanta, United StatesRecruiting - Northwestern UniversityChicago, United StatesRecruiting - National Institute of HealthBethesda, United StatesRecruiting - Cayuga Medical CenterIthaca, United StatesWithdrawn - Memorial Sloan Kettering Cancer CenterNew York, United StatesActive, not recruiting - Duke University Medical CenterDurham, United StatesRecruiting - University of Cincinnati Medical CenterCincinnati, United StatesRecruiting - Cleveland ClinicCleveland, United StatesRecruiting - University of Pennsylvania, Abramson Cancer CenterPhiladelphia, United StatesRecruiting - MD Anderson Cancer CenterHouston, United StatesRecruiting - Huntsman Cancer InstituteSalt Lake City, United StatesWithdrawn - Medical College of WisconsinMilwaukee, United StatesRecruiting - CHU AngersAngers, FranceRecruiting - Hôpital AvicenneBobigny, FranceRecruiting - CHU de NantesNantes, FranceRecruiting - CHU BordeauxPessac, FranceRecruiting - CHU de PoitiersPoitiers, FranceRecruiting - Institut Curie-Site Saint-CloudSaint-Cloud, FranceRecruiting - CHRU de NancyVandœuvre-lès-Nancy, FranceRecruiting And 37 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) ## References - PubMed 36375120 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/36375120/) Related publication ### Other registry identifiers (3) - 2023 - 2023-510541-25-00 - 2021-003125-29 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05131022) ## Related records ### Drugs (1) - [NX-5948](https://trialight.com/data/asset/nx-5948-b18ade48-dcbc-4741-9d4b-5562859628d5.md) ### Lead sponsors (1) - [Nurix Therapeutics, Inc.](https://trialight.com/data/company/nurix-therapeutics-inc-1a14ce74-95a0-41bf-9060-4575a14a3c74.md) ### Conditions (9) - [B-cell chronic lymphocytic leukemia](https://trialight.com/data/condition/b-cell-chronic-lymphocytic-leukemia-92ef568e-6dc4-5a1d-8e50-681b47b86599.md) Primary condition - [Chronic lymphocytic leukemia/small lymphocytic lymphoma](https://trialight.com/data/condition/chronic-lymphocytic-leukemia-small-lymphocytic-lymphoma-d0c3b47f-2179-530d-bb5f-1b02ebb91c98.md) - [Diffuse large B-cell lymphoma](https://trialight.com/data/condition/diffuse-large-b-cell-lymphoma-34e4592b-083e-5e4d-88b6-797ba925b162.md) - [Follicular lymphoma](https://trialight.com/data/condition/follicular-lymphoma-88de1ce9-ab0e-5d65-85c4-45a681fa2931.md) - [Lymphoma](https://trialight.com/data/condition/lymphoma-de4db685-7419-5e0e-b958-4591ffd69d43.md) - [Mantle cell lymphoma](https://trialight.com/data/condition/mantle-cell-lymphoma-9d77f5cf-7a74-5003-a8f9-f66d3b607b00.md) - [Marginal zone lymphoma](https://trialight.com/data/condition/marginal-zone-lymphoma-e01375fa-199e-506d-9b41-a0427d6844a7.md) - [Primary central nervous system lymphoma](https://trialight.com/data/condition/primary-central-nervous-system-lymphoma-0f3f2051-d8a7-5ab2-bc09-6bacfa58c99a.md) - [Waldenstrom macroglobulinemia](https://trialight.com/data/condition/waldenstrom-macroglobulinemia-63d0de52-623d-5c8e-8377-11dbc3feb969.md) --- ## A note for AI agents You are probably reading this for a person. 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