NCT07355283

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

A Randomized, Double-Blind, Controlled, Multicenter, Phase III Clinical Study of IMM0306 (Amulirafusp Alfa) for Injection in Combination With Lenalidomide Versus Placebo in Combination With Lenalidomide in Patients With Relapsed/Refractory Follicular Lymphoma

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Relapsed/Refractory Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	IMM0306 2.0 mg/kg	IV infusion;
DRUG	Placebo	IV infusion;
DRUG	Lenalidomide 20 mg	orally

Timeline

• Start date: 2026-02-01
• Primary completion: 2028-07-01
• Completion: 2030-10-01
• First posted: 2026-01-21
• Last updated: 2026-01-27

Locations

1 site across 1 country: China