SCTB35 plus Lenalidomide for relapsed or refractory follicular lymphoma
Official title: A Phase 3 Randomized, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Lenalidomide Versus Rituximab and Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma
Run by Sinocelltech Ltd. · NCT07562022 · Data updated 2026-11-12
This trial tests whether SCTB35 given with Lenalidomide can help people whose follicular lymphoma has come back or stopped responding to prior treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 93 (estimated) |
| Sponsor | Sinocelltech Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | June 9, 2026 |
| Main results expected | May 2028 |
| Study ends | June 2029 |
| Registry record updated | August 13, 2026 |
| Trial ID | NCT07562022 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18-80 with histologically confirmed FL (grade 1–3a), relapsed/refractory after prior anti-CD20–containing therapy, measurable disease, ECOG 0-2, and adequate organ function who meet GELF criteria for systemic treatment.
✕Probably not a fit
Patients with lenalidomide refractoriness or recent lenalidomide exposure, or those not meeting eligibility criteria, may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a phase 3 interventional study evaluating the safety and efficacy of SCTB35 in combination with Lenalidomide in adults with relapsed or refractory follicular lymphoma. Participants receive SCTB35 injections alongside Rituximab and Lenalidomide to determine if the combo improves disease control. Eligible patients are 18 to 80 years old with confirmed FL, measurable disease, good performance status, and adequate organ function, and who require systemic therapy per GELF criteria. Exclusion includes prior lenalidomide refractoriness and recent lenalidomide exposure. The study is led by Sinocelltech Ltd. with Beijing Cancer Hospital as a participating site.
Why it matters
Potential benefit: If successful, the treatment could improve responses and extend survival for people with relapsed or refractory FL.
How similar studies have gone: Prior approaches combining targeted therapies with immunotherapy have shown promise in FL, but this specific SCTB35 plus Lenalidomide approach is being investigated for its potential additive benefit.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.