Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
572
Countries
5
Sites
28
Relapsed/Refractory B-cell Malignancies
Key facts
- Sponsor
- Nurix Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 9 Oct 2023 → ongoing
- Decision date (initial)
- 2024-09-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-510541-25-00
- EudraCT number
- 2021-003125-29
- ClinicalTrials.gov
- NCT05131022
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed/Refractory B-cell Malignancies
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10003908 | B-cell small lymphocytic lymphoma | 100000004864 |
| 21.1 | LLT | 10068919 | B-cell chronic lymphocytic leukemia | 10029104 |
| 20.0 | PT | 10061275 | Mantle cell lymphoma | 100000004864 |
| 21.0 | LLT | 10036685 | Primary central nervous system lymphoma | 10029104 |
| 21.0 | PT | 10012818 | Diffuse large B-cell lymphoma | 100000004864 |
| 24.0 | LLT | 10080214 | Follicular B-cell non-Hodgkin´s lymphoma unclassifiable | 10029104 |
| 21.0 | PT | 10062113 | Splenic marginal zone lymphoma | 100000004864 |
| 24.0 | LLT | 10067070 | Follicular B-cell non-Hodgkin´s lymphoma | 10029104 |
| 21.1 | LLT | 10054693 | Von Waldenstrom macroglobulinemia | 10029104 |
| 20.0 | PT | 10076596 | Marginal zone lymphoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Nurix Therapeutics Inc.
- Sponsor organisation
- Nurix Therapeutics Inc.
- Address
- 1600 Sierra Point Parkway
- City
- Brisbane
- Postcode
- 94005-1809
- Country
- United States
Scientific contact point
- Organisation
- Nurix Therapeutics Inc.
- Contact name
- Sarah Injac
Public contact point
- Organisation
- Nurix Therapeutics Inc.
- Contact name
- Sarah Injac
Locations
5 EU/EEA countries · 28 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 40 | 7 |
| Italy | Ongoing, recruiting | 40 | 6 |
| Netherlands | Ongoing, recruiting | 40 | 3 |
| Poland | Ongoing, recruiting | 90 | 7 |
| Spain | Ongoing, recruiting | 40 | 5 |
| Rest of world
Switzerland, United States, United Kingdom
|
— | 322 | — |
Investigational sites
Centre Hospitalier Universitaire D Angers
Services des Maladies du sang, 4 Rue Larrey, 49933, Angers Cedex 9
Centre Hospitalier Universitaire De Nantes
Clinical Hematology, 1 Place Alexis Ricordeau, 44000, Nantes
CHRU De Nancy
Hematology, 11 Rue Du Morvan, Bp 80001, Vandoeuvre Les Nancy Cedex
Centre Hospitalier Universitaire De Poitiers
Hematology, 2 Rue De La Miletrie, 86000, Poitiers
Institut Curie
Oncology, 35 Rue Dailly, 92210, Saint-Cloud
Hôpital Haut-Lévêque
Hematology and Cell Therapy, 1 Avenue Magellan, France, Pessac
Hôpital Avicenne
Unite de Recherche Clinique/ Centre de Recherche Clinique, 125 rue de Stalingrad, 93000, Bobigny
IRCCS Azienda Ospedaliero Universitaria - Policlinico di Sant'Orsola
Dipartimento Malattie Oncologiche ed Ematologiche, Via Albertoni 15, 40138, Bologna
San Raffaele Hospital
Strategic Research Program on CLL, Via Olgettina 58, 20132, Milan
ASST Spedali Civili di Brescia
Hematology, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
SCDU Hematology, Via Venezia 16, 15121, Alexandria
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Oncology and Hematology, Largo Francesco Vito 1, 00168, Rome
IRCCS San Raffaele Scientific Institute
Oncology and Onco-hematology, Via Olgettina 60, 20132, Milan
Radboud universitair medisch centrum / RADBOUDUMC
Hematology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Universitair Medisch Centrum Utrecht
Hematology, Heidelberglaan 100, 3584 CX, Utrecht
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Hematology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Pratia Onkologia Katowice
Hematology, Tadeusza Kościuszki, 92, Katowice
Aidport Sp. z o.o.
Hematology, Stanislawa Moniuszki 2, 60-185, Skorzewo
Wroclaw Medical University
Hematology, Ul. Wybrzeze Ludwika Pasteura 1, 50-367, Wroclaw
Pratia MCM Krakow
Lymphoid Malignancy Department, Pana Tadeusza 2, 30-727, Krakow
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Hematology, Ul. Dra Kazimierza Jaczewskiego 8, 20-090, Lublin
Mtz Clinical Research Powered By Pratia
Hematology, Ul. Gładka 22, 02-172, Warsaw
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Oncology, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Hospital Universitario De Cabueñes
Hematology, Calle Los Prados 395, 33203, Gijón
Hospital Universitario Fundación Jiménez Díaz
Hematology, Av. de los Reyes Católicos, 2, Madrid
Hospital Universitario Ramón y Cajal
Hematology, Ctra. De Colmenar Viejo Km. 9,100, 28034, Madrid
Hospital Universitari Vall D Hebron
Hematology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Clínic Barcelona
Hematology, Villarroel 170, 08036, Barcelona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2025-03-26 | 2025-03-26 | |||
| Italy | 2025-04-22 | 2025-04-22 | |||
| Netherlands | 2023-10-09 | 2024-10-09 | |||
| Poland | 2024-10-21 | 2024-10-21 | |||
| Spain | 2025-03-18 | 2025-03-18 |
Application history
13 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-14 | Netherlands | Acceptable 2024-03-07
|
2024-03-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-21 | Netherlands | Acceptable 2024-06-07
|
2024-06-07 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2024-06-25 | Acceptable 2024-06-07
|
2024-09-12 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-06-25 | Acceptable 2024-06-07
|
2024-09-17 | |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2024-06-25 | Acceptable 2024-06-07
|
2024-09-23 | |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2024-06-25 | 2024-09-22 | ||
| 7 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-15 | Netherlands | Acceptable 2025-03-03
|
2025-03-03 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-03-19 | Netherlands | Acceptable 2025-03-03
|
2025-03-19 |
| 9 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-21 | Netherlands | Acceptable 2025-06-10
|
2025-06-11 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-06-20 | Acceptable 2025-06-10
|
2025-06-20 | |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-07-03 | Acceptable 2025-06-10
|
2025-07-03 | |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2026-02-23 | Netherlands | Acceptable 2025-06-10
|
2026-02-23 |
| 13 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-02-28 | Netherlands | Acceptable 2026-06-02
|
2026-06-02 |