The purpose of this study is to evaluate the efficacy and safety of SCTB35 in Combination With Lenalidomide in Patients With Relapsed or Refractory Follicular lymphoma (FL).
Age 18-80 years old
Histologically confirmed Follicular lymphoma (FL) grade 1, 2, or 3a according to WHO 2022 criteria
Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy
Judged by the investigator, the participant must urgently need to receive systemic treatment, based on meeting at least one GELF criterion
Documented refractoriness to lenalidomide.
Have lenalidomide exposure within 12 months prior to randomization
Parallel
SCTB35 injection
DrugSCTB35 will be subcutaneously administered at a dose as specified
Rituximab
DrugIntravenous Infusion
Lenalidomide
DrugOral Capsules
Adverse Events
Treatment-emergent adverse events/serious adverse events/adverse events of special interest
Progression free survival (PFS)
Defined as the time from the date of randomization to the date of first documentation of progression disease (PD) or the date of death from any cause, whichever occurs first.
Percentage of Participants Achieving Best Overall Response (BOR)
BOR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria
Percentage of Participants Achieving CR
Percentage of participants who achieve a CR determined per Lugano criteria.
Overall Survival (OS)
Overall survival is defined as the duration from the date of randomization to the date of the participant's death.
Duration of Response (DOR)
DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first.
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