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Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)
Sponsor: Ichnos Sciences SA
Summary
This study is a first-in-human, Phase 1, open-label study that will evaluate safety and anti-myeloma activity of ISB 2001 in participants with relapsed/refractory multiple myeloma (R/R MM).
Official title: A Phase 1, First-in-Human, Multicenter, Open-Label, Dose Escalation and Dose-Expansion Study of Single-Agent ISB 2001 in Subjects With Relapsed/Refractory Multiple Myeloma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2023-11-01
Completion Date
2027-07
Last Updated
2026-04-01
Healthy Volunteers
No
Conditions
Interventions
ISB 2001
Participants receive escalating doses of ISB 2001
ISB 2001
Participants receive injection of ISB 2001 as determined in Part 1.
Locations (32)
Standford Cancer Institute
Palo Alto, California, United States
Sylvester Cancer Center
Miami, Florida, United States
Winship Cancer Institute
Atlanta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Tennessee Oncology
Nashville, Tennessee, United States
Virginia Commonwealth University (VCU)
Richmond, Virginia, United States
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Concord Hospital
Concord, New South Wales, Australia
Pindara Private Hospital
Benowa, Queensland, Australia
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Peter MacCallum Cancer Center
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
CHRU Lille
Lille, Hauts-de-France, France
CHU Poiters - Hospital la Miletrie
Poitiers, Nouvelle-Aquitaine, France
CHU de Nantes - Hotel Dieu
Nantes, Pays de la Loire Region, France
Groupe Hospitalier Pitie-Salpetriere
Paris, Île-de-France Region, France
Apollo Hospital International Limited
Gandhinagar, Gujarat, India
Health Care Global Enterprises Ltd.
Bangalore, Karnataka, India
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashta, India
Apollo Cancer Centers
Hyderabad, Telangana, India
HCG Hospital
Bangalore, India
ASST Spedali Civili di Brescia
Brescia, Lombardy, Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
Oslo University Hospital
Oslo, Oslo County, Norway
Instituto de Investigacion Biomedica de Salamanca (IBSAL)
Salamanca, Castile de Leon, Spain
Institut Catala de Oncologia (ICO)
Badalona, Catalonia, Spain
Hospital Clinic de Barcelona
Barcelona, Catalonia, Spain
Centro Integral Oncologici Clara Campal
Madrid, Madrid, Spain
Clinica Universidad de Nevarra
Pamplona, Navarre, Spain