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
- Diseases
- Multiple myeloma
- 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
Sites (34)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pindara Private Hospital Coordinator of this site? Confirm its status | Benowa | Australia | Recruiting |
| Concord Hospital Coordinator of this site? Confirm its status | Concord | Australia | Recruiting |
| St Vincent's Hospital Melbourne Coordinator of this site? Confirm its status | Fitzroy | Australia | Recruiting |
| Peter MacCallum Cancer Center Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Linear Clinical Research Coordinator of this site? Confirm its status | Nedlands | Australia | Recruiting |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Hopital Saint Antoine Coordinator of this site? Confirm its status | Paris Cedex 12 | France | Recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 13 | France | Recruiting |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
| Health Care Global Enterprises Ltd. Coordinator of this site? Confirm its status | Bangalore | India | Active, not recruiting |
| HCG Hospital Coordinator of this site? Confirm its status | Bangalore | India | Active, not recruiting |
| Apollo Hospital International Limited Coordinator of this site? Confirm its status | Gandhinagar | India | Active, not recruiting |
| Apollo Cancer Centers Coordinator of this site? Confirm its status | Hyderabad | India | Active, not recruiting |
| Deenanath Mangeshkar Hospital and Research Centre Coordinator of this site? Confirm its status | Pune | India | Active, not recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of North Carolina Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| University of Chicago Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Sylvester Cancer Center Coordinator of this site? Confirm its status | Miami | United States | Active, not recruiting |
| Froedtert Hospital & the Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| Tennessee Oncology Coordinator of this site? Confirm its status | Nashville | United States | Active, not recruiting |
| Standford Cancer Institute Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| Virginia Commonwealth University (Vcu) Coordinator of this site? Confirm its status | Richmond | United States | Active, not recruiting |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
Related publications
- Clinical Validation of a QSP Model for ISB 2001, a Trispecific T Cell Engager to Support Optimal FIH Study Design in RRMM Patients.Clin Pharmacol Ther · 2026 · PMID 42206665
This page is information, not medical advice. Discuss any trial with your doctor.