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

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 Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
2. At least one measurable lesion (as per Lugano 2014 criteria).
3. Histologically confirmed CD20-positive Follicular Lymphoma, Grade 1, 2, or 3a.
4. Previously received at least two prior systemic regimens, including at least one line containing an anti-CD20 monoclonal antibody.
5. Adequate hepatic, hematologic, and renal function.
6. Expected survival at least 6 months.

Exclusion Criteria:

1. Autologous HSCT within 100 days prior to first administration, or any prior allogeneic HSCT or solid organ transplantation.
2. History of central nervous system (CNS) metastases or active CNS involvement.
3. History of other malignancy within the past 5 years.
4. Severe organic cardiovascular or cerebrovascular diseases.
5. History of severe allergic reactions to any components of the trial drug, any macromolecular protein preparations or monoclonal antibodies.
6. Previous treatment with anti-CD47 monoclonal antibody/SIRPα fusion protein.
7. Human immunodeficiency virus (HIV) infection.
8. Echocardiography examination indicating left ventricular ejection fraction (LVEF) < 55%.
9. Active infection requiring systemic therapy (e.g., fungal, bacterial, viral).