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.
Parallel
IMM0306 2.0 mg/kg
DrugIV infusion;
Placebo
DrugIV infusion;
Lenalidomide 20 mg
Drugorally
Complete remission rate(CRR) as Assessed by Investigator
CRR is defined as the percentage of participants who achieve a CR(Complete Response) determined per Lugano 2014 criteria (2014 Lugano Revised Response Criteria for Malignant Lymphoma).
Progression-Free Survival (PFS) as Assessed by Investigator
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
Complete remission rate(CRR) as Assessed by Independent Review Committee(IRC)
CRR is defined as the percentage of participants who achieve a CR determined per Lugano 2014 criteria.
Progression-Free Survival (PFS) as Assessed by Independent Review Committee(IRC)
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
Objective Response Rate (ORR)
ORR is defined as the proportion of the analysis population achieving CR, PR(Partial Response).
Duration of Response (DOR)
DOR is defined as the time from the first documented evidence of complete response or partial response until disease progression or death due to any cause, whichever occurs first.
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