Clinical Trial

A Open-Label Phase in Participants With Multiple Myeloma

Not Yet Recruiting Phase 2
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Summary
This is an open-label, multi-center phase II study of IBI3003 in combination with anti-CD38 monoclonal antibody in adult subjects with multiple myeloma. This study includes a safety run-in period and 2 cohorts (Cohorts 1 and 2).In the safety run-in period, subjects with measurable relapsed or refractory multiple myeloma who had previously received at least 1 line of systemic anti-myeloma therapy and had a history of dual drug exposure (at least one proteasome inhibitor and one immunomodulatory agent) were enrolled, mainly to evaluate the safety and tolerability of IBI3003 in combination with anti-CD38 monoclonal antibody and to determine the recommended phase 2 dose of IBI3003 in combination with anti-CD38 monoclonal antibody.Cohort 1 mainly enrolls newly diagnosed MM(Multiple myeloma)patients who are ineligible for or refusing ASCT(Autologous Stem Cell Transplantation), and Cohort 2 enrolls newly diagnosed MM patients who are eligible for and willing to undergo ASCT. The 24-week MRD negative rate of IBI3003 in combination with anti-CD38 monoclonal antibody in the participant population is mainly evaluated.
Trial Details
NCT Number NCT07764861
Lead Sponsor Innovent Biologics (Suzhou) Co. Ltd.
Conditions Multiple Myeloma
Enrollment 120 participants
Start Date 2026-08-15
Primary Completion 2026-12-31 (estimated)
Study Completion 2031-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-14