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

RecruitingPhase 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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

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

Exclusion Criteria:

1. Active malignant central nervous system involvement
2. Uncontrolled infection requiring systemic antibiotic therapy or other serious infection prior to C1D1
3. History of autoimmune disease requiring systemic immunosuppressive therapy
4. 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.
5. 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.

About the study

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).

What is being tested

Sponsor: Ichnos Sciences SA · Participants: 200 · Started: Nov 1, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05862012

Locations in the U.S.

CaliforniaStandford Cancer Institute, Palo Alto
GeorgiaWinship Cancer Institute, Atlanta
IllinoisUniversity of Chicago Medical Center, Chicago
MassachusettsBeth Israel Deaconess Medical Center, Boston
New YorkMontefiore Medical Center, The Bronx
North CarolinaUniversity of North Carolina, Chapel Hill
WisconsinFroedtert Hospital & the Medical College of Wisconsin, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.