Tests IMM0306 with lenalidomide in relapsed follicular lymphoma
Tests IMM0306 plus lenalidomide against placebo in adults with follicular lymphoma that returned.
Plain-language title generated from the registry record
Registry title: IMM0306 in Combination With Lenalidomide vs Placebo in Combination With Lenalidomide in Patients With Relapsed/Refractory Follicular Lymphoma
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 3
Where in China
- Beijing Cancer HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
- Trial code
- NCT07355283
- Record updated
- 27 January 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; At least one measurable lesion (as per Lugano 2014 criteria); Histologically confirmed CD20-positive Follicular Lymphoma, Grade 1, 2, or 3a; Previously received at least two prior systemic regimens, including at least one line containing an anti-CD20 monoclonal antibody; Adequate hepatic, hematologic, and renal function; Expected survival at least 6 months.
Exclusion: Autologous HSCT within 100 days prior to first administration, or any prior allogeneic HSCT or solid organ transplantation; Previous treatment with anti-CD47 monoclonal antibody/SIRPα fusion protein; History of central nervous system (CNS) metastases or active CNS involvement; History of other malignancy within the past 5 years; Severe organic cardiovascular or cerebrovascular diseases; History of severe allergic reactions to any components of the trial drug, any macromolecular protein preparations or monoclonal antibodies; Human immunodeficiency virus (HIV) infection; Active infection requiring systemic therapy (e.g., fungal, bacterial, viral); Echocardiography examination indicating left ventricular ejection fraction (LVEF) < 55%.