Clinical Trials in China / NCT07562022
Recruiting
Phase 3
A Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma
NCT07562022 · tracked via the Priya Life Science China tracker
Condition(s) studied
Follicular Lymphoma (FL)
Investigational drug(s) / intervention(s)
SCTB35 injection: SCTB35 will be subcutaneously administered at a dose as specified
Rituximab: Intravenous Infusion
Lenalidomide: Oral Capsules
Study summary
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
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
Primary outcome measure(s)
- Adverse Events — Up to approximately 3 years
Treatment-emergent adverse events/serious adverse events/adverse events of special interest - Progression free survival (PFS) — Up to approximately 3 years
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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | Recruiting |
More Sinocelltech Ltd. trials in China
Other trials for the same condition
Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07562022 on ClinicalTrials.gov ↗ ← All trials in China