Clinical trial • Phase I • Oncology|Haematology

NX-5948 for Relapsed or refractory B-cell malignancies | Diffuse large B-cell lymphoma | Mantle cell lymphoma | Follicular lymphoma | Marginal zone lymphoma | Splenic marginal zone lymphoma | B-cell chronic lymphocytic leukemia | Waldenström macroglobulinemia | Primary central nervous system lymphoma | B-cell small lymphocytic lymphoma

Phase I trial of NX-5948 for Relapsed or refractory B-cell malignancies | Diffuse large B-cell lymphoma | Mantle cell lymphoma | Follicular lymphoma | Mar…

Overview

Trial Therapeutic Area
Oncology|Haematology
Trial Disease
Relapsed or refractory B-cell malignancies | Diffuse large B-cell lymphoma | Mantle cell lymphoma | Follicular lymphoma | Marginal zone lymphoma | Splenic marginal zone lymphoma | B-cell chronic lymphocytic leukemia | Waldenström macroglobulinemia | Primary central nervous system lymphoma | B-cell small lymphocytic lymphoma
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
14-02-2024
First CTIS Authorization Date
07-03-2024

Trial design

Phase I trial in Netherlands, France, Italy and others.

Target Sample Size
322

Recruitment

Planned Sample Size
322
Recruitment Window Months
40

Geography

Total Number Of Sites
32
Total Number Of Participants
250

Netherlands

Earliest CTIS Part Ii Submission Date
22-02-2024
Latest Decision Or Authorization Date
07-06-2024
Processing Time Days
106
Number Of Sites
4
Number Of Participants
40

Sites

Site Name
Universitair Medisch Centrum Groningen
Department Name
Hematology
Principal Investigator Name
Marcel Nijland
Principal Investigator Email
m.nijland@umcg.nl
Contact Person Name
Marcel Nijland
Contact Person Email
m.nijland@umcg.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Hematology
Principal Investigator Name
Astrid Pulles
Principal Investigator Email
a.e.pulles-3@umcutrecht.nl
Contact Person Name
Astrid Pulles
Contact Person Email
a.e.pulles-3@umcutrecht.nl
Site Name
Radboud universitair medisch centrum / RADBOUDUMC
Department Name
Hematology
Principal Investigator Name
Wendy Stevens
Principal Investigator Email
wendy.stevens@radboudumc.nl
Contact Person Name
Wendy Stevens
Contact Person Email
wendy.stevens@radboudumc.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Hematology
Principal Investigator Name
Jeanette Doorduijn
Principal Investigator Email
j.doorduijn@erasmusmc.nl
Contact Person Name
Jeanette Doorduijn
Contact Person Email
j.doorduijn@erasmusmc.nl

France

Earliest CTIS Part Ii Submission Date
03-09-2024
Latest Decision Or Authorization Date
12-09-2024
Processing Time Days
9
Number Of Sites
7
Number Of Participants
40

Sites

Site Name
Centre Hospitalier Universitaire D Angers
Department Name
Services des Maladies du sang
Principal Investigator Name
Aline Clavert
Principal Investigator Email
aline.clavert@chu-angers.fr
Contact Person Name
Aline Clavert
Contact Person Email
aline.clavert@chu-angers.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Hematology
Principal Investigator Name
Cecile Tomowiak
Principal Investigator Email
cecile.tomowiak@chu-poitiers.fr
Contact Person Name
Cecile Tomowiak
Site Name
Hôpital Haut-Lévêque
Department Name
Hematology and Cell Therapy
Principal Investigator Name
Kamal-Krimo Bouabdallah
Principal Investigator Email
krimo.bouabdallah@chu-bordeaux.fr
Contact Person Name
Kamal-Krimo Bouabdallah
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Clinical Hematology
Principal Investigator Name
Benoit Tessoulin
Principal Investigator Email
benoit.tessoulin@chu-nantes.fr
Contact Person Name
Benoit Tessoulin
Contact Person Email
benoit.tessoulin@chu-nantes.fr
Site Name
CHRU De Nancy
Department Name
Hematology
Principal Investigator Name
Pierre Feugier
Principal Investigator Email
p.feugier@chru-nancy.fr
Contact Person Name
Pierre Feugier
Contact Person Email
p.feugier@chru-nancy.fr
Site Name
Hôpital Avicenne
Department Name
Unite de Recherche Clinique/ Centre de Recherche Clinique
Principal Investigator Name
Vincent Levy
Principal Investigator Email
vincent.levy@aphp.fr
Contact Person Name
Vincent Levy
Contact Person Email
vincent.levy@aphp.fr
Site Name
Institut Curie
Department Name
Oncology
Principal Investigator Name
Clementine Sarkozy
Principal Investigator Email
clementine.sarkozy@curie.fr
Contact Person Name
Clementine Sarkozy
Contact Person Email
clementine.sarkozy@curie.fr

Italy

Earliest CTIS Part Ii Submission Date
11-09-2024
Latest Decision Or Authorization Date
17-09-2024
Processing Time Days
6
Number Of Sites
7
Number Of Participants
40

Sites

Site Name
ASST Spedali Civili di Brescia
Department Name
Hematology
Principal Investigator Name
Alessandra Tucci
Principal Investigator Email
alessandra.tucci@asst-spedalicivili.it
Contact Person Name
Alessandra Tucci
Site Name
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Department Name
SCDU Hematology
Principal Investigator Name
Marco Ladetto
Principal Investigator Email
marco.ladetto@uniupo.it
Contact Person Name
Marco Ladetto
Contact Person Email
marco.ladetto@uniupo.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Oncology and Hematology
Principal Investigator Name
Luca Laurenti
Principal Investigator Email
luca.laurenti@unicatt.it
Contact Person Name
Luca Laurenti
Contact Person Email
luca.laurenti@unicatt.it
Site Name
San Raffaele Hospital
Department Name
Strategic Research Program on CLL
Principal Investigator Name
Paola Ghia
Principal Investigator Email
ghia.paolo@hsr.it
Contact Person Name
Paola Ghia
Contact Person Email
ghia.paolo@hsr.it
Site Name
IRCCS Azienda Ospedaliero Universitaria - Policlinico di Sant'Orsola
Department Name
Dipartimento Malattie Oncologiche ed Ematologiche
Principal Investigator Name
Pier Zinzani
Principal Investigator Email
pierluigi.zinzani@unibo.it
Contact Person Name
Pier Zinzani
Contact Person Email
pierluigi.zinzani@unibo.it
Site Name
IRCCS San Raffaele Scientific Institute
Department Name
Oncology and Onco-hematology
Principal Investigator Name
Andrés Ferreri
Principal Investigator Email
ferreri.andres@hsr.it
Contact Person Name
Andrés Ferreri
Contact Person Email
ferreri.andres@hsr.it
Site Name
IRCCS San Raffaele Scientific Institute (secondary entry)
Department Name
Oncology and Onco-hematology
Principal Investigator Name
Andrés Ferreri
Principal Investigator Email
ferreri.andres@hsr.it
Contact Person Name
Andrés Ferreri
Contact Person Email
ferreri.andres@hsr.it

Poland

Earliest CTIS Part Ii Submission Date
21-08-2024
Latest Decision Or Authorization Date
22-09-2024
Processing Time Days
32
Number Of Sites
9
Number Of Participants
90

Sites

Site Name
Wroclaw Medical University
Department Name
Hematology
Principal Investigator Name
Tomasz Wróbel
Principal Investigator Email
tomaszwrobel@wp.pl
Contact Person Name
Tomasz Wróbel
Contact Person Email
tomaszwrobel@wp.pl
Site Name
Pratia Onkologia Katowice
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
badacz@pratia.com
Contact Person Name
Iwona Hus
Contact Person Email
badacz@pratia.com
Site Name
Pratia MCM Krakow
Department Name
Lymphoid Malignancy Department
Principal Investigator Name
Wojciech Jurczak
Principal Investigator Email
wojciech.jurczak@pratia.com
Contact Person Name
Wojciech Jurczak
Contact Person Email
wojciech.jurczak@pratia.com
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Oncology
Principal Investigator Name
Joanna Romejko–Jarosińska
Principal Investigator Email
joanna.romejko-jarosinska@pib-nio.pl
Contact Person Name
Joanna Romejko–Jarosińska
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
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Department Name
Hematology
Principal Investigator Name
Krzysztof Giannopoulos
Principal Investigator Email
krzysztof.giannopoulos@gmail.com
Contact Person Name
Krzysztof Giannopoulos
Site Name
Pratia site (Warsaw)
Department Name
Hematology
Principal Investigator Name
Iwona Hus
Principal Investigator Email
badacz@pratia.com
Contact Person Name
Iwona Hus
Contact Person Email
badacz@pratia.com
Site Name
Pratia MCM Krakow (additional entry)
Department Name
Lymphoid Malignancy Department
Principal Investigator Name
Wojciech Jurczak
Principal Investigator Email
wojciech.jurczak@pratia.com
Contact Person Name
Wojciech Jurczak
Contact Person Email
wojciech.jurczak@pratia.com

Spain

Earliest CTIS Part Ii Submission Date
21-08-2024
Latest Decision Or Authorization Date
23-09-2024
Processing Time Days
33
Number Of Sites
5
Number Of Participants
40

Sites

Site Name
Hospital Universitario Fundación Jiménez Díaz
Department Name
Hematology
Principal Investigator Name
Daniel Morillo Giles
Principal Investigator Email
dmorillo@startmadrid.com
Contact Person Name
Daniel Morillo Giles
Contact Person Email
dmorillo@startmadrid.com
Site Name
Hospital Universitario De Cabueñes
Department Name
Hematology
Principal Investigator Name
Ruben Fernandez-Alvarez
Principal Investigator Email
rubenfalva@gmail.com
Contact Person Name
Ruben Fernandez-Alvarez
Contact Person Email
rubenfalva@gmail.com
Site Name
Hospital Clínic Barcelona
Department Name
Hematology
Principal Investigator Name
Pablo Mozas
Principal Investigator Email
mozas@clinic.cat
Contact Person Name
Pablo Mozas
Contact Person Email
mozas@clinic.cat
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology
Principal Investigator Name
Pablo Abrisqueta
Principal Investigator Email
pabrisqueta@vhio.net
Contact Person Name
Pablo Abrisqueta
Contact Person Email
pabrisqueta@vhio.net
Site Name
Hospital Universitario Ramón y Cajal
Department Name
Hematology
Principal Investigator Name
Javier Lopez-Jimenez
Principal Investigator Email
jljimenez@salud.madrid.org
Contact Person Name
Javier Lopez-Jimenez
Contact Person Email
jljimenez@salud.madrid.org

Sponsor

Primary sponsor

Full Name
Nurix Therapeutics Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
NX-5948

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