Tests ISB 2001 in adults with relapsed or refractory multiple myeloma
Tests ISB 2001 alone in adults whose multiple myeloma returned or did not respond.
Plain-language title generated from the registry record
Registry title: Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)
Key facts
- Where
- Atlanta, Boston, Chapel Hill, Chicago, Miami, Milwaukee, Nashville, Palo Alto, Richmond, and The Bronx, United StatesSee the 10 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose multiple myeloma has come back or has stopped responding to treatment. They must have measurable myeloma in blood or urine tests.
- Age
- 18 years and older
- Sex
- All sexes can join.
- Disease stage
- Multiple myeloma that has come back or has not responded to treatment (relapsed/refractory), confirmed by lab tests, with measurable M-protein (in serum and/or 24-hour urine), serum-free light chains, or a measurable isolated plasmacytoma.
- Biomarker or test result
- Measurable M-protein in blood or 24-hour urine, serum-free light chains, or a measurable isolated plasmacytoma.
Main reasons for not taking part
- Active myeloma in the brain or spinal cord area (central nervous system)
- Uncontrolled infection needing antibiotics through the body, or another serious infection
- Autoimmune disease that needed medicines to calm the immune system
- Women who are breastfeeding or have a positive pregnancy test
- Other uncontrolled health, mental or social problems that could affect safety or taking part in the trial
Read by machine on 9 November 2026.
Where in United States
- Winship Cancer InstituteAtlanta, United StatesTaking people
- Beth Israel Deaconess Medical CenterBoston, United StatesTaking people
- University of North CarolinaChapel Hill, United StatesTaking people
- University of Chicago Medical CenterChicago, United StatesTaking people
- Sylvester Cancer CenterMiami, United StatesNo longer taking part
- Froedtert Hospital & the Medical College of WisconsinMilwaukee, United StatesTaking people
- Tennessee OncologyNashville, United StatesNo longer taking part
- Standford Cancer InstitutePalo Alto, United StatesTaking people
- Virginia Commonwealth University (Vcu)Richmond, United StatesNo longer taking part
- Montefiore Medical CenterThe Bronx, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ichnos Sciences SA
- Trial code
- NCT05862012EU 2023-507071-21-01
- Record updated
- 1 April 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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.
Exclusion: 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; Active malignant central nervous system involvement; History of autoimmune disease requiring systemic immunosuppressive therapy; 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.