Ichnos Sciences SA
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).
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 diseas…
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…
Participants receive escalating doses of ISB 2001
Participants receive injection of ISB 2001 as determined in Part 1.