NCT07562022

Brief 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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P25-P50 for phase_3

Timeline
38mo left

Started May 2026

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026Jun 2029

First Submitted

Initial submission to the registry

April 24, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

April 24, 2026

Last Update Submit

April 24, 2026

Conditions

Follicular Lymphoma (FL)

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (10)

  • Percentage of Participants Achieving Best Overall Response (BOR)

    Up to approximately 3 years

  • Percentage of Participants Achieving CR

    Up to approximately 3 years

  • Overall Survival (OS)

    Up to approximately 3 years

  • Duration of Response (DOR)

    Up to approximately 3 years

  • Time to Response (TTR)

    Up to approximately 3 years

  • +5 more secondary outcomes

Study Arms (2)

SCTB35 and Lenalidomide

EXPERIMENTAL
Drug: SCTB35 injectionDrug: Lenalidomide

Rituximab and Lenalidomide

ACTIVE COMPARATOR
Drug: RituximabDrug: Lenalidomide

Interventions

SCTB35 injectionDRUG

SCTB35 will be subcutaneously administered at a dose as specified

SCTB35 and Lenalidomide
RituximabDRUG

Intravenous Infusion

Rituximab and Lenalidomide
LenalidomideDRUG

Oral Capsules

Rituximab and LenalidomideSCTB35 and Lenalidomide

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

RituximabLenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2026

First Posted

May 1, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

June 1, 2029

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations

CN(1)