drugset / Trial / NCT07828522

F182112 in Combination With Isatuximab and Lenalidomide for the Treatment of Patients With Newly Diagnosed Multiple Myeloma

NCT07828522 ↗

Phase 2 Not yet recruiting 10 enrolled Institute of Hematology & Blood Diseases Hospital, China
NaSingle-groupOpen-labelTreatment

Summary

This is a prospective, single-center, single-arm, exploratory pilot study designed to evaluate the safety, feasibility, and preliminary efficacy of F182112 in combination with isatuximab and lenalidomide in transplant-eligible patients with newly diagnosed multiple myeloma. The study will also explore preliminary proof-of-concept signals of deep responses and minimal residual disease (MRD) negativity with this regimen, thereby informing the design of a subsequent phase II clinical trial.

Timeline

Start
2026-10-01
Primary completion
2027-10-09
Completion
2028-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject F182112 Monoclonal antibody 180 ug/kg Intravenous
Subject Isatuximab Monoclonal antibody 10 mg/kg Intravenous
Subject Lenalidomide Other / unclassified 25 mg Oral

Indications