Clinical trial • Phase I • Haematology
ISB 2001 for Relapsed/Refractory Multiple myeloma
Phase I trial of ISB 2001 for Relapsed/Refractory Multiple myeloma. 115 participants.
Overview
- Trial Therapeutic Area
- Haematology
- Trial Disease
- Relapsed/Refractory Multiple myeloma
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 28-02-2025
- First CTIS Authorization Date
- 16-06-2025
Trial design
Phase I trial across 15 sites in France, Italy, Spain and others.
- Target Sample Size
- 115
Eligibility
Recruits 115 Vulnerable population selected (isVulnerablePopulationSelected=true); no further details on consent or assent handling provided in the available records..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected=true); no further details on consent or assent handling provided in the available records.
Recruitment
- Planned Sample Size
- 115
- Recruitment Window Months
- 30
Geography
- Total Number Of Sites
- 15
- Total Number Of Participants
- 85
France
- Earliest CTIS Part Ii Submission Date
- 11-04-2025
- Latest Decision Or Authorization Date
- 07-04-2026
- Processing Time Days
- 361
- Number Of Sites
- 5
- Number Of Participants
- 25
Sites
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Maladies du sang
- Principal Investigator Name
- Salomon Manier
- Principal Investigator Email
- salomon.manier@chru-lille.fr
- Contact Person Name
- Salomon Manier
- Contact Person Email
- salomon.manier@chru-lille.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Hematology
- Principal Investigator Name
- Xavier Leleu
- Principal Investigator Email
- xavier.leleu@chu-poitiers.fr
- Contact Person Name
- Xavier Leleu
- Contact Person Email
- xavier.leleu@chu-poitiers.fr
- Site Name
- Hopital Saint Antoine
- Department Name
- Hematology
- Principal Investigator Name
- Mohamad Mohty
- Principal Investigator Email
- mohamad.mohty@inserm.fr
- Contact Person Name
- Mohamad Mohty
- Contact Person Email
- mohamad.mohty@inserm.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Hematology
- Principal Investigator Name
- Cyrille Touzeau
- Principal Investigator Email
- Cyrille.touzeau@chu-nantes.fr
- Contact Person Name
- Cyrille Touzeau
- Contact Person Email
- Cyrille.touzeau@chu-nantes.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Haematology
- Principal Investigator Name
- Laurent Garderet
- Principal Investigator Email
- Laurent.garderet@aphp.fr
- Contact Person Name
- Laurent Garderet
- Contact Person Email
- Laurent.garderet@aphp.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 19-05-2025
- Latest Decision Or Authorization Date
- 09-04-2026
- Processing Time Days
- 325
- Number Of Sites
- 3
- Number Of Participants
- 15
Sites
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- S.C. Hematology
- Principal Investigator Name
- Matteo Da Vià
- Principal Investigator Email
- matteo.davia@policlinico.mi.it
- Contact Person Name
- Matteo Da Vià
- Contact Person Email
- matteo.davia@policlinico.mi.it
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- U.O.C. Ematologia
- Principal Investigator Name
- Angelo Belotti
- Principal Investigator Email
- ange.belotti@gmail.com
- Contact Person Name
- Angelo Belotti
- Contact Person Email
- ange.belotti@gmail.com
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- U.O di Oncologia Medica ed Ematologia
- Principal Investigator Name
- Carmelo Carlo-Stella
- Principal Investigator Email
- carmelo.carlostella@hunimed.eu
- Contact Person Name
- Carmelo Carlo-Stella
- Contact Person Email
- carmelo.carlostella@hunimed.eu
Spain
- Earliest CTIS Part Ii Submission Date
- 06-05-2025
- Latest Decision Or Authorization Date
- 13-04-2026
- Processing Time Days
- 342
- Number Of Sites
- 6
- Number Of Participants
- 25
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Hematology
- Principal Investigator Name
- Gala Vega Achabal
- Principal Investigator Email
- Gala.Vega@startmadrid.com
- Contact Person Name
- Gala Vega Achabal
- Contact Person Email
- Gala.Vega@startmadrid.com
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Hematology
- Principal Investigator Name
- María Victoria Mateos
- Principal Investigator Email
- mvmateos@usal.es
- Contact Person Name
- María Victoria Mateos
- Contact Person Email
- mvmateos@usal.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Hematology
- Principal Investigator Name
- Laura Rosiñol Dachs
- Principal Investigator Email
- LROSINOL@clinic.cat
- Contact Person Name
- Laura Rosiñol Dachs
- Contact Person Email
- LROSINOL@clinic.cat
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Hematology
- Principal Investigator Name
- Paula Rodríguez Otero
- Principal Investigator Email
- paurodriguez@unav.es
- Contact Person Name
- Paula Rodríguez Otero
- Contact Person Email
- paurodriguez@unav.es
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Hematology
- Principal Investigator Name
- Damián Cubillas García de la Torre
- Principal Investigator Email
- Damian.Cubillas@startmadrid.com
- Contact Person Name
- Damián Cubillas García de la Torre
- Contact Person Email
- Damian.Cubillas@startmadrid.com
- Site Name
- Institut Catala D'oncologia
- Department Name
- Hematology
- Principal Investigator Name
- Laura Abril Sabater
- Principal Investigator Email
- labril@iconcologia.net
- Contact Person Name
- Laura Abril Sabater
- Contact Person Email
- labril@iconcologia.net
Norway
- Earliest CTIS Part Ii Submission Date
- 06-05-2025
- Latest Decision Or Authorization Date
- 09-04-2026
- Processing Time Days
- 338
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- Oslo University Hospital HF
- Department Name
- Oslo Myeloma Center
- Principal Investigator Name
- Fredrik Schjesvold
- Principal Investigator Email
- fredrikschjesvold@gmail.com
- Contact Person Name
- Fredrik Schjesvold
- Contact Person Email
- fredrikschjesvold@gmail.com
Sponsor
Primary sponsor
- Full Name
- IGI Therapeutics S.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- ISB 2001
- First In Human
- Yes
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