Phase 1 Study of ISB 2001 for Adults with Relapsed or Refractory Multiple Myeloma Evaluating Safety and Optimal Dose with Weekly Treatments

What this Trial Is About

Researchers are evaluating ISB 2001 in adults with relapsed or refractory multiple myeloma RR MM who have already been treated with immunomodulatory drugs, proteasome inhibitors, and anti-CD38 therapies but remain resistant or intolerant to these treatments. This first-in-human, Phase 1, open-label study aims to assess the safety and anti-myeloma activity of ISB 2001. The study is sponsored by Ichnos Sciences SA and involves participants who have measurable disease and adequate organ function. The study has two parts dose escalation and dose expansion. In the dose escalation phase, participants receive increasing doses of ISB 2001 to determine the maximum safe dose. In the dose expansion phase, participants receive ISB 2001 at the optimal dose identified to further confirm safety and biological activity. ISB 2001 is given weekly on Days 1, 8, 15, and 22 of each 28-day cycle, with an additional step-up dose on Day 4 of Cycle 1. Treatment continues until disease progression, unacceptable side effects, or withdrawal. Participants will undergo regular monitoring for treatment-emergent adverse events and dose-limiting toxicities during the first cycle, with follow-up visits extending up to 18 months. Researchers will measure drug levels in the blood, immune responses to the drug, and multiple clinical outcomes related to disease response and progression. Ongoing assessments will include physical exams, performance status, and laboratory tests to track safety and treatment effects throughout the study period.

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)