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NCT Number: NCT07562022

A Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With 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).

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Key information

Conditions

Follicular Lymphoma (FL) Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SCTB35 injection

Drug

SCTB35 will be subcutaneously administered at a dose as specified

Rituximab

Drug

Intravenous Infusion

Lenalidomide

Drug

Oral Capsules

Primary outcomes

  1. Adverse Events

    Time frame: Up to approximately 3 years

    Treatment-emergent adverse events/serious adverse events/adverse events of special interest

  2. Progression free survival (PFS)

    Time frame: 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.

Secondary outcomes

  1. Percentage of Participants Achieving Best Overall Response (BOR)

    Time frame: Up to approximately 3 years

    BOR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria

  2. Percentage of Participants Achieving CR

    Time frame: Up to approximately 3 years

    Percentage of participants who achieve a CR determined per Lugano criteria.

  3. Overall Survival (OS)

    Time frame: Up to approximately 3 years

    Overall survival is defined as the duration from the date of randomization to the date of the participant's death.

  4. Duration of Response (DOR)

    Time frame: Up to approximately 3 years

    DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first.

  5. Time to Response (TTR)

    Time frame: Up to approximately 3 years

    Time to response is defined for participants achieving a CR/PR as the time from starting therapy to first a CR/PR.

  6. Event-Free Survival (EFS)

    Time frame: Up to approximately 3 years

    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).

  7. Duration of Complete Response (DOCR)

    Time frame: Up to approximately 3 years

    DOCR is defined as the time from the first occurrence of CR to disease progression or death, whichever occurs first.

  8. Time to Complete Response (TTCR)

    Time frame: Up to approximately 3 years

    Time to complete response is defined for participants achieving a CR as the time from starting therapy to first a CR.

  9. Blood Concentrations of SCTB35

    Time frame: Up to approximately 1 years

    The pharmacokinetics of SCTB35 will be analyzed based on the drug concentrations at respective timepoints in the blood samples (or blood derivative)

  10. Anti-drug Antibodies of SCTB35

    Time frame: Up to approximately 3 years

    Blood samples (or blood derivative) will be screened for antibodies binding to SCTB35

Sponsors and collaborators

Lead sponsor

Sinocelltech Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 1, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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