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Not yet recruiting NCT07570823

A Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Phase III Interventional DLBCL - Diffuse Large B Cell Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SCTB35 injection, Rituxumab, Gemcitabine, Oxaliplatin.
Who it may be relevant to
Registry conditions: DLBCL - Diffuse Large B Cell Lymphoma. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Phase 3 Randomized, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Gemcitabine and Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Overview

The purpose of this study is to evaluate the efficacy and safety of SCTB35 in Combination With Gemcitabine and Oxaliplatin vs Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma.

Interventions

  • Drug SCTB35 injection
    SCTB35 will be subcutaneously administered at a dose as specified
  • Drug Rituxumab
    Participants will receive IV rituxumab on Day 1 of each cycle for up to 8 cycles.
  • Drug Gemcitabine
    Participants will receive IV gemcitabine administration for up to 8 cycles.
  • Drug Oxaliplatin
    Participants will receive IV oxaliplatin administration for up to 8 cycles.

Primary outcome measures

  • Adverse Events [Time frame: Up to approximately 3 years]
  • Progression free survival (PFS) [Time frame: Up to approximately 3 years]
Secondary outcome measures (10)
  • Overall Survival (OS) [Time frame: Up to approximately 3 years]
  • Percentage of Participants Achieving Best Overall Response (BOR) [Time frame: Up to approximately 3 years]
  • Percentage of Participants Achieving CR [Time frame: Up to approximately 3 years]
  • Duration of Response (DOR) [Time frame: Up to approximately 3 years]
  • Duration of Complete Response (DOCR) [Time frame: Up to approximately 3 years]
  • Time to Response (TTR) [Time frame: Up to approximately 3 years]
  • Time to Complete Response (TTCR) [Time frame: Up to approximately 3 years]
  • Event-Free Survival (EFS) [Time frame: Up to approximately 3 years]
  • Blood Concentrations of SCTB35 [Time frame: Up to approximately 1 years]
  • Anti-drug Antibodies of SCTB35 [Time frame: Up to approximately 3 years]

Eligibility criteria

Inclusion criteria

  • Age 18-80 years old
  • Histologically confirmed diffuse large B-cell lymphoma according to WHO 2022 criteria
  • Relapsed or refractory (R/R) disease following at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy
  • Participants who have failed after one prior line of therapy are not candidates for high-dose chemotherapy followed by autologous stem cell transplant (ASCT)
  • Presence of measurable or evaluable disease at baseline ECOG PS 0-2
  • ECOG PS 0-2
  • Adequate organ function and bone marrow function
  • Expected survival ≥ 3 months

Exclusion criteria

  • Prior treatment with antibodies targeting both CD20 and CD3
  • Contraindication to rituximab, gemcitabine or oxaliplatin, or prior treatment with an anti-CD20 antibody in combination with the GemOx regimen
  • Peripheral neuropathy assessed to be Grade >1 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v6.0 at enrollment
  • Known central nervous system (CNS) involvement by lymphoma
  • Known any major episode of active infection requiring treatment with systemic antibiotics within 2 weeks
  • Treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 100 days prior to first SCTB35 administration
  • Autologous HSCT within 100 days prior to first SCTB35 administration, or any prior allogeneic HSCT or solid organ transplantation
  • Major surgery within 4 weeks prior to first SCTB35 administration
  • Chemotherapy and other non-investigational antineoplastic agents (except CD20 mAbs) within 4 weeks or 5 half-lives (whichever is shorter) prior to first SCTB35 administration
  • Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Cancer Hospital — Beijing

Identifiers

NCT: NCT07570823 · SCTB35-B301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗