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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Follicular Lymphoma (FL)
• Intervention / Treatment: Drug: Rituximab; Drug: Lenalidomide; Drug: SCTB35 injection

• Study Type: Interventional
• Enrollment (Estimated): 93
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SCTB35 and Lenalidomide	Drug: Lenalidomide; Oral Capsules; Drug: SCTB35 injection; SCTB35 will be subcutaneously administered at a dose as specified
Active Comparator: Rituximab and Lenalidomide	Drug: Rituximab; Intravenous Infusion; Drug: Lenalidomide; Oral Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Treatment-emergent adverse events/serious adverse events/adverse events of special interest	Up to approximately 3 years
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.	Up to approximately 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Best Overall Response (BOR)	BOR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria	Up to approximately 3 years
Percentage of Participants Achieving CR	Percentage of participants who achieve a CR determined per Lugano criteria.	Up to approximately 3 years
Overall Survival (OS)	Overall survival is defined as the duration from the date of randomization to the date of the participant's death.	Up to approximately 3 years
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.	Up to approximately 3 years
Time to Response (TTR)	Time to response is defined for participants achieving a CR/PR as the time from starting therapy to first a CR/PR.	Up to approximately 3 years
Event-Free Survival (EFS)	EFS is defined as the duration from randomization to disease progression determined by Lugano criteria as assessed by the investigator, initiation of any non-protocol-specified new anti-lymphoma therapy for any reason, or death (whichever occurs first).	Up to approximately 3 years
Duration of Complete Response (DOCR)	DOCR is defined as the time from the first occurrence of CR to disease progression or death, whichever occurs first.	Up to approximately 3 years
Time to Complete Response (TTCR)	Time to complete response is defined for participants achieving a CR as the time from starting therapy to first a CR.	Up to approximately 3 years
Blood Concentrations of SCTB35	The pharmacokinetics of SCTB35 will be analyzed based on the drug concentrations at respective timepoints in the blood samples (or blood derivative)	Up to approximately 1 years
Anti-drug Antibodies of SCTB35	Blood samples (or blood derivative) will be screened for antibodies binding to SCTB35	Up to approximately 3 years

Collaborators and Investigators

• Sponsor: Sinocelltech Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, Follicular; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carboxylic Acids; Piperidines; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Murine-Derived; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Piperidones; Isoindoles; Lenalidomide; Rituximab
• Other Study ID Numbers: SCTB35-A301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No