Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma
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).
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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 CRITERIA
Exclusion Criteria:
- 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.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Relapsed/Refractory Multiple Myeloma
Age
18+
Phase
PHASE1
Participants Needed
80
Est. Completion Date
Jul 31, 2027
Treatment Type
INTERVENTIONAL
Sponsor
Ichnos Sciences SA
ClinicalTrials.gov NCT Identifier
NCT05862012
Study Number
ISB 2001-101
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