Clinical trial • Phase II • Oncology
NX-5948 for Chronic lymphocytic leukemia (relapsed/refractory) | Small lymphocytic lymphoma (relapsed/refractory)
Phase II trial of NX-5948 for Chronic lymphocytic leukemia (relapsed/refractory) | Small lymphocytic lymphoma (relapsed/refractory).
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Chronic lymphocytic leukemia (relapsed/refractory) | Small lymphocytic lymphoma (relapsed/refractory)
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 10-06-2025
- First CTIS Authorization Date
- 02-10-2025
Trial design
open-label, none/not specified-controlled Phase II trial across 10 sites in France, Hungary, Italy and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 62
Eligibility
Recruits 62 Vulnerable population selected (isVulnerablePopulationSelected: true). Subject information and informed consent forms are included in the submission (documents titled 'L1_SIS and ICF' and country-specific ICFs). No explicit assent/consent age-specific handling text is present in the record..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected: true). Subject information and informed consent forms are included in the submission (documents titled 'L1_SIS and ICF' and country-specific ICFs). No explicit assent/consent age-specific handling text is present in the record.
Inclusion criteria
- {"criterion_text":"- Age: ≥ 18 years\n- Confirmed diagnosis of CLL/SLL that meets iwCLL criteria diagnosis and systemic treatment (Hallek 2018)\n- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n- Prior exposure to a cBTKI, a ncBTKi, and a BCL2i either in separate lines of treatment or in combination\n- Measurable disease by computed tomography (CT) per iwCLL\n- Adequate organ and bone marrow function"}
Exclusion criteria
- {"criterion_text":"- Known or suspected prolymphocytic leukemia or Richter’s transformation at any time preceding enrolment. Note: In cases of clinical suspicion of Richter's Transformation, the treating physician may determine if histopathological evaluation should be performed and results reviewed by the treating physician to rule out transformation prior to enrollment.\n- Investigational agent or anticancer therapy within 5 half-lives or 14 days (whichever is shorter) before planned start of study drug.\n- Radiotherapy within 2 weeks of the first dose of study treatment\n- Use of systemic corticosteroids >20 mg/day prednisone or equivalent within the 7 days prior to initiation of study drug excepting those used as prophylaxis for radio diagnostic contrast\n- Use of systemic immunosuppressive drugs other than systemic corticosteroids for any medical condition within 60 days prior to first dose of study drug\n- Previously treated with a BTK degrader"}
Endpoints
Primary endpoints
- {"endpoint_text":"- ORR (without PR-L) as assessed by IRC","definition_or_measurement_approach":"Overall response rate assessed by an Independent Review Committee (IRC). Translations indicate ORR components include complete response (CR)/CR with incomplete recovery (CRi) + partial response (PR) + nodal PR (nPR)."}
Secondary endpoints
- {"endpoint_text":"- ORR with PR-L as assessed by IRC","definition_or_measurement_approach":"ORR including PR-L assessed by IRC"}
- {"endpoint_text":"- DOR as assessed by IRC and by investigator","definition_or_measurement_approach":"Duration of response assessed by IRC and by investigator"}
- {"endpoint_text":"- PFS as assessed by IRC and by investigator","definition_or_measurement_approach":"Progression-free survival assessed by IRC and by investigator"}
- {"endpoint_text":"- Complete response rate as assessed by IRC and by investigator","definition_or_measurement_approach":"Complete response rate (CR + CRi) assessed by IRC and investigator"}
- {"endpoint_text":"- TTR as assessed by IRC and by investigator","definition_or_measurement_approach":"Time to response assessed by IRC and investigator"}
- {"endpoint_text":"- OS","definition_or_measurement_approach":"Overall survival"}
- {"endpoint_text":"- Including, but not limited to, incidence and severity of TEAEs, SAEs and TEAEs leading to study drug discontinuation","definition_or_measurement_approach":"Safety endpoints including treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to discontinuation"}
- {"endpoint_text":"- Changes from baseline in laboratory parameters and vital signs","definition_or_measurement_approach":"Laboratory and vital sign changes from baseline"}
- {"endpoint_text":"- Summary measures of PK trough concentrations","definition_or_measurement_approach":"Pharmacokinetic trough concentration summary measures of NX-5948"}
- {"endpoint_text":"- ORR (with and without PR-L) as assessed by investigator","definition_or_measurement_approach":"Investigator-assessed ORR with and without PR-L"}
- {"endpoint_text":"- PROs measured by EORTC QLQ-C30 and EQ-5D-5L questionnaires","definition_or_measurement_approach":"Patient-reported outcomes measured by EORTC QLQ-C30 and EQ-5D-5L"}
Recruitment
- Planned Sample Size
- 62
- Recruitment Window Months
- 60
- Consent Approach
- Informed consent is obtained using subject information and informed consent forms (documents titled 'L1_SIS and ICF' and country-specific ICFs). Country/language versions available in the submission include English and country-specific versions (French, Polish, Italian, Hungarian) as indicated by the presence of translated ICF and protocol synopsis documents. Specific assent procedures or age-differentiated consent text are not detailed in the record.
Geography
- Total Number Of Sites
- 10
- Total Number Of Participants
- 41
France
- Earliest CTIS Part Ii Submission Date
- 11-09-2025
- Latest Decision Or Authorization Date
- 02-10-2025
- Processing Time Days
- 21
- Number Of Sites
- 1
- Number Of Participants
- 11
Sites
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Département Hématologie
- Principal Investigator Name
- Anne Lok
- Principal Investigator Email
- anne.lok@chu-nantes.fr
- Contact Person Name
- Anne Lok
- Contact Person Email
- anne.lok@chu-nantes.fr
Hungary
- Earliest CTIS Part Ii Submission Date
- 05-08-2025
- Latest Decision Or Authorization Date
- 03-10-2025
- Processing Time Days
- 59
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- University Of Debrecen
- Department Name
- Haematology
- Principal Investigator Name
- Arpad Illes
- Principal Investigator Email
- illesarpaddr@gmail.com
- Contact Person Name
- Arpad Illes
- Contact Person Email
- illesarpaddr@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 03-07-2025
- Latest Decision Or Authorization Date
- 03-10-2025
- Processing Time Days
- 92
- Number Of Sites
- 4
- Number Of Participants
- 16
Sites
- Site Name
- San Raffaele Ospedale
- Department Name
- Strategic Research Program on CLL
- Principal Investigator Name
- Paolo Prospero Ghia
- Principal Investigator Email
- ghia.paolo@hsr.it
- Contact Person Name
- Paolo Prospero Ghia
- Contact Person Email
- ghia.paolo@hsr.it
- Site Name
- IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
- Department Name
- Dipartimento Malattie Oncologiche ed Ematologiche
- Principal Investigator Name
- Pier Luigi Zinzani
- Principal Investigator Email
- pierluigi.zinzani@unibo.it
- Contact Person Name
- Pier Luigi Zinzani
- Contact Person Email
- pierluigi.zinzani@unibo.it
- Site Name
- Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo
- Department Name
- SCDU Hematology
- Principal Investigator Name
- Gioacchino Catania
- Principal Investigator Email
- gioacchino.catania@ospedale.al.it
- Contact Person Name
- Gioacchino Catania
- Contact Person Email
- gioacchino.catania@ospedale.al.it
- Site Name
- Ospedale Santa Maria delle Croci
- Department Name
- Haematology
- Principal Investigator Name
- Monica Tani
- Principal Investigator Email
- monica.tani@auslromagna.it
- Contact Person Name
- Monica Tani
- Contact Person Email
- monica.tani@auslromagna.it
Poland
- Earliest CTIS Part Ii Submission Date
- 01-09-2025
- Latest Decision Or Authorization Date
- 06-10-2025
- Processing Time Days
- 35
- Number Of Sites
- 4
- Number Of Participants
- 11
Sites
- Site Name
- Aidport Sp. z o.o.
- Department Name
- Hematology
- Principal Investigator Name
- Michal Kwiatek
- Principal Investigator Email
- michal.kwiatek@aidport.pl
- Contact Person Name
- Michal Kwiatek
- Contact Person Email
- michal.kwiatek@aidport.pl
- Site Name
- Pratia MCM Krakow
- Department Name
- Lymphoid Malignancy Department
- Principal Investigator Name
- Wojciech Jurczak
- Principal Investigator Email
- adrosik-kwasniewska@pratia.com
- Contact Person Name
- Wojciech Jurczak
- Contact Person Email
- adrosik-kwasniewska@pratia.com
- Site Name
- Pratia Hematologia Sp. z o.o.
- Department Name
- Hematology
- Principal Investigator Name
- Sebastian Grosicki
- Principal Investigator Email
- sgrosicki@wp.pl
- Contact Person Name
- Sebastian Grosicki
- Contact Person Email
- sgrosicki@wp.pl
- Site Name
- Mtz Clinical Research Powered By Pratia
- Department Name
- Hematology
- Principal Investigator Name
- Iwona Hus
- Principal Investigator Email
- iwonach.hus@gmail.com
- Contact Person Name
- Iwona Hus
- Contact Person Email
- iwonach.hus@gmail.com
Sponsor
Primary sponsor
- Full Name
- Nurix Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Medpace Inc.
- Responsibilities
- codes: 1,12,2,7,8
- Name
- Suvoda LLC
- Responsibilities
- Treatment Randomisation
- Name
- Perceptive Informatics Inc.
- Responsibilities
- Medical Image Analysis/Review - x-ray, MRI, ultrasound, etc
- Name
- Edetek Inc.
- Responsibilities
- code: 7
Third parties
- {"country":"United Kingdom","full_name":"NeoGenomics Inc","duties_or_roles":"NGS","organisation_type":"Health care"}
- {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"MRD and IGHV","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medpace Inc.","duties_or_roles":"codes: 1,12,2,7,8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Alturas Analytics Inc.","duties_or_roles":"PK Plasma","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Clinical Chemistry, Clinical Haematology and Serology/Endocrinology","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Neogenomics Inc","duties_or_roles":"FISH and Cytogenetics","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"Treatment Randomisation","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Medical Image Analysis/Review - x-ray, MRI, ultrasound, etc","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Edetek Inc.","duties_or_roles":"code: 7","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Rules Based Medicine Inc.","duties_or_roles":"Chemokines/Cytokines","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"Labcorp Early Development Laboratories Limited","duties_or_roles":"Flow Cytometry","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- NX-5948
- Active Substance
- NX-5948
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Orphan Designation
- Yes
- Maximum Dose
- 600 mg per day (maxDailyDoseAmount: 600)
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