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).
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.
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.