RecruitingPhase 1NCT05862012
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
Sponsor
Ichnos Sciences SA
Enrollment
200 participants
Start Date
Nov 1, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- 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 Criteria5
- Active malignant central nervous system involvement
- Uncontrolled infection requiring systemic antibiotic therapy or other serious infection prior to C1D1
- History of autoimmune disease requiring systemic immunosuppressive therapy
- 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.
- 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.
Interventions
DRUGISB 2001
Participants receive escalating doses of ISB 2001
DRUGISB 2001
Participants receive injection of ISB 2001 as determined in Part 1.
Locations(11)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05862012
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