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

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Relapsed/Refractory Follicular Lymphoma

In brief

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).

Key facts

Study ID

NCT07355283

Run by

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

People needed

198

Starts

2026-02-01

Expected to finish

2030-10-01

Last updated by the study team

2026-01-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Autologous HSCT within 100 days prior to first administration, or any prior allogeneic HSCT or solid organ transplantation.
• 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.
• Previous treatment with anti-CD47 monoclonal antibody/SIRPα fusion protein.
• Human immunodeficiency virus (HIV) infection.
• Echocardiography examination indicating left ventricular ejection fraction (LVEF) < 55%.
• Active infection requiring systemic therapy (e.g., fungal, bacterial, viral).

Where it is running

• Beijing Cancer Hospital — Beijing, China

Full record on ClinicalTrials.gov

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