drugset / Trial / NCT07355283

IMM0306 in Combination With Lenalidomide vs Placebo in Combination With Lenalidomide in Patients With Relapsed/Refractory Follicular Lymphoma

NCT07355283

Phase 3 Not yet recruiting 198 enrolled ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This study is a randomized, controlled, double-blind, multicenter, phase III clinical study to evaluate the efficacy of IMM0306 (Amulirafusp Alfa)in combination with lenalidomide versus placebo in combination with lenalidomide in patients with Relapsed/Refractory Follicular lymphoma. Primary endpoints are Complete Remission Rate (CRR) and Progression-Free Survival (PFS).

Timeline

Start
2026-02
Primary completion
2028-07
Completion
2030-10

Drugs

EvaluationDrugModalityDoseRoute
Subject IMM0306 Protein / enzyme biologic 2 mg/kg Intravenous
Background Lenalidomide Other / unclassified 20 mg Oral

Indications