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NCT05862012RecruitingPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 1 Apr 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
200 (estimated)
First submitted
4 May 2023
Start date
1 Nov 2023
Primary completion date
31 Jul 2027
Lead sponsor
Ichnos Sciences SA
NCT number
NCT05862012
EU CT number
2023-507071-21-01

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 200
  • From 1 Nov 2023 to the primary completion date, 31 Jul 2027
  • 34 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Uncontrolled infection requiring systemic antibiotic therapy or other serious infection prior to C1D1
  • 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.

Other illness

  • Active malignant central nervous system involvement
  • History of autoimmune disease requiring systemic immunosuppressive therapy

Other

  • 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.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (34)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Pindara Private Hospital
Coordinator of this site? Confirm its status
BenowaAustraliaRecruiting
Concord Hospital
Coordinator of this site? Confirm its status
ConcordAustraliaRecruiting
St Vincent's Hospital Melbourne
Coordinator of this site? Confirm its status
FitzroyAustraliaRecruiting
Peter MacCallum Cancer Center
Coordinator of this site? Confirm its status
MelbourneAustraliaRecruiting
Linear Clinical Research
Coordinator of this site? Confirm its status
NedlandsAustraliaRecruiting
Institut Catala d'Oncologia
Coordinator of this site? Confirm its status
BadalonaSpainRecruiting
Hospital Clinic de Barcelona
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Universitario Fundación Jiménez Díaz
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario HM Sanchinarro
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Clínica Universidad de navarra
Coordinator of this site? Confirm its status
PamplonaSpainRecruiting
Hospital Universitario De Salamanca
Coordinator of this site? Confirm its status
SalamancaSpainRecruiting
Centre Hospitalier Universitaire de Lille
Coordinator of this site? Confirm its status
LilleFranceRecruiting
Centre Hospitalier Universitaire de Nantes
Coordinator of this site? Confirm its status
NantesFranceRecruiting
Hopital Saint Antoine
Coordinator of this site? Confirm its status
Paris Cedex 12FranceRecruiting
Assistance Publique Hopitaux De Paris
Coordinator of this site? Confirm its status
Paris Cedex 13FranceRecruiting
Centre Hospitalier Universitaire de Poitiers
Coordinator of this site? Confirm its status
PoitiersFranceRecruiting
Health Care Global Enterprises Ltd.
Coordinator of this site? Confirm its status
BangaloreIndiaActive, not recruiting
HCG Hospital
Coordinator of this site? Confirm its status
BangaloreIndiaActive, not recruiting
Apollo Hospital International Limited
Coordinator of this site? Confirm its status
GandhinagarIndiaActive, not recruiting
Apollo Cancer Centers
Coordinator of this site? Confirm its status
HyderabadIndiaActive, not recruiting
Deenanath Mangeshkar Hospital and Research Centre
Coordinator of this site? Confirm its status
PuneIndiaActive, not recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Coordinator of this site? Confirm its status
BresciaItalyRecruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Oslo University Hospital HF
Coordinator of this site? Confirm its status
OsloNorwayRecruiting
Winship Cancer Institute
Coordinator of this site? Confirm its status
AtlantaUnited StatesRecruiting
Beth Israel Deaconess Medical Center
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
University of North Carolina
Coordinator of this site? Confirm its status
Chapel HillUnited StatesRecruiting
University of Chicago Medical Center
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
Sylvester Cancer Center
Coordinator of this site? Confirm its status
MiamiUnited StatesActive, not recruiting
Froedtert Hospital & the Medical College of Wisconsin
Coordinator of this site? Confirm its status
MilwaukeeUnited StatesRecruiting
Tennessee Oncology
Coordinator of this site? Confirm its status
NashvilleUnited StatesActive, not recruiting
Standford Cancer Institute
Coordinator of this site? Confirm its status
Palo AltoUnited StatesRecruiting
Virginia Commonwealth University (Vcu)
Coordinator of this site? Confirm its status
RichmondUnited StatesActive, not recruiting
Montefiore Medical Center
Coordinator of this site? Confirm its status
The BronxUnited StatesRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.