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
- Bangalore, Gandhinagar, Hyderabad, and Pune, IndiaSee the 5 sites
- Phase
- Phase 1
Where in India
- HCG HospitalBangalore, IndiaNo longer taking part
- Health Care Global Enterprises Ltd.Bangalore, IndiaNo longer taking part
- Apollo Hospital International LimitedGandhinagar, IndiaNo longer taking part
- Apollo Cancer CentersHyderabad, IndiaNo longer taking part
- Deenanath Mangeshkar Hospital and Research CentrePune, IndiaNo longer taking part
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.