Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)

Recruiting now · Phase 1

Conditions studied: Relapsed/Refractory Multiple Myeloma

In brief

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).

Key facts

Study ID

NCT05862012

Run by

Ichnos Sciences SA

People needed

200

Starts

2023-11-01

Expected to finish

2027-07-01

Last updated by the study team

2026-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with pathologically confirmed MM with measurable M-protein: serum and/or 24 hour urine, serum-free light chains or measurable isolated plasmacytoma
• Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
• Must have adequate hematologic, hepatic, renal, and cardiac functions

You may not qualify if…

• Active malignant central nervous system involvement
• Uncontrolled infection requiring systemic antibiotic therapy or other serious infection prior to C1D1
• History of autoimmune disease requiring systemic immunosuppressive therapy
• Any concurrent or uncontrolled medical, comorbid, psychiatric or social condition that would limit compliance with study procedures, interfere with the study results, substantially increase the risk of AEs, compromise ability to provide written informed consent or, in the opinion of the Investigator, constitute a hazard for participating in this study.
• Female subjects who are lactating and breastfeeding or have a positive pregnancy test during the screening period or on Day 1 before first dose of ISB 2001.

Where it is running

• Clinica Universidad de Nevarra — Pamplona, Navarre, Spain (enrolling)
• CHRU Lille — Lille, Hauts-de-France, France (enrolling)
• CHU Poiters - Hospital la Miletrie — Poitiers, New Aquitaine, France (enrolling)
• CHU de Nantes - Hotel Dieu — Nantes, Pays de la Loire Region, France (enrolling)
• Groupe Hospitalier Pitie-Salpetriere — Paris, Île-de-France Region, France (enrolling)
• Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico — Milan, Lombardy, Italy (enrolling)
• Oslo University Hospital — Oslo, Oslo, Norway (enrolling)
• Instituto de Investigacion Biomedica de Salamanca (IBSAL) — Salamanca, Castile de Leon, Spain (enrolling)
• Institut Catala de Oncologia (ICO) — Badalona, Catalonia, Spain (enrolling)
• Hospital Clinic de Barcelona — Barcelona, Catalonia, Spain (enrolling)
• Standford Cancer Institute — Palo Alto, California, United States (enrolling)
• Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)
• University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• Montefiore Medical Center — The Bronx, New York, United States (enrolling)
• University of North Carolina — Chapel Hill, North Carolina, United States (enrolling)
• Froedtert Hospital & the Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
• Concord Hospital — Concord, New South Wales, Australia (enrolling)
• Pindara Private Hospital — Benowa, Queensland, Australia (enrolling)
• St. Vincent's Hospital Melbourne — Fitzroy, Victoria, Australia (enrolling)
• Peter MacCallum Cancer Center — Melbourne, Victoria, Australia (enrolling)
• Linear Clinical Research — Nedlands, Western Australia, Australia (enrolling)
• Sylvester Cancer Center — Miami, Florida, United States
• Centro Integral Oncologici Clara Campal — Madrid, Madrid, Spain
• Apollo Hospital International Limited — Gandhinagar, Gujarat, India

Full record on ClinicalTrials.gov

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