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A Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma

NCT07562022

RecruitingPhase 3

Sponsor: Sinocelltech Ltd.

Conditions: Follicular Lymphoma (FL)

Interventions: SCTB35 injection, Rituximab, Lenalidomide

Countries: China

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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
* A measurable or evaluable disease at the time of enrolment
* ECOG PS 0-2
* Adequate organ function and bone marrow function
* Expected survival ≥ 6 months

Exclusion Criteria:

* Documented refractoriness to lenalidomide.
* Have lenalidomide exposure within 12 months prior to randomization

Locations (1)

Beijing, Beijing Municipality, China