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Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)
Trial Status: active
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.
Additional locations may be listed on ClinicalTrials.gov for NCT05862012.
Locations matching your search criteria
United States
California
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Name Not Available
Georgia
Atlanta
Emory University Hospital/Winship Cancer Institute
Status: Approved
Name Not Available
Illinois
Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available
New York
Bronx
Montefiore Medical Center-Weiler Hospital
Status: Active
Name Not Available
North Carolina
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Name Not Available
The study will enroll 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 will be conducted in two parts:
- Part 1: Dose escalation
- Part 2: Dose expansion
Dose escalation will continue until either the maximum tolerated dose (MTD) is defined,
the maximum planned dose is reached, or a recommended phase 2 dose (RP2D) is selected.
Dose expansion cohorts will be initiated to further confirm safety and optimal
biologically active dose. Participants will receive ISB 2001 until disease progression,
unacceptable toxicity occurs, any criterion for stopping the study treatment, or
