Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)
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 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
- 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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05862012.
Locations matching your search criteria
United States
California
Palo Alto
Florida
Coral Gables
Coral Springs
Deerfield Beach
Doral
Miami
North Miami
Plantation
Georgia
Atlanta
Illinois
Chicago
Massachusetts
Boston
New York
Bronx
North Carolina
Chapel Hill
Virginia
Richmond
The study enrolls participants with R/R MM that have been treated with immunomodulatory
drugs (IMiDs), proteasome inhibitors, and anti-CD38 therapies either in combination or as
a single agent and are refractory to, or intolerant of, established therapies known to
provide clinical benefit in MM.
The study is conducted in two parts: Part 1 dose escalation and Part 2 dose expansion.
Dose escalation continued until the maximum planned dose was reached. Dose expansion
cohorts were initiated to further confirm safety and optimal biologically active dose.
Participants receive ISB 2001 until disease progression, unacceptable toxicity occurs,
any criterion for stopping the study treatment, or participant withdrawal from the study.
Trial PhasePhase I
Trial Typetreatment
Lead OrganizationIchnos Sciences SA
- Primary IDISB 2001-101
- Secondary IDsNCI-2023-09473
- ClinicalTrials.gov IDNCT05862012