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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Adverse Events [Срок оценки: Up to approximately 3 years]
• Progression free survival (PFS) [Срок оценки: Up to approximately 3 years]

Вторичные конечные точки (10)

• Overall Survival (OS) [Срок оценки: Up to approximately 3 years]
• Percentage of Participants Achieving Best Overall Response (BOR) [Срок оценки: Up to approximately 3 years]
• Percentage of Participants Achieving CR [Срок оценки: Up to approximately 3 years]
• Duration of Response (DOR) [Срок оценки: Up to approximately 3 years]
• Duration of Complete Response (DOCR) [Срок оценки: Up to approximately 3 years]
• Time to Response (TTR) [Срок оценки: Up to approximately 3 years]
• Time to Complete Response (TTCR) [Срок оценки: Up to approximately 3 years]
• Event-Free Survival (EFS) [Срок оценки: Up to approximately 3 years]
• Blood Concentrations of SCTB35 [Срок оценки: Up to approximately 1 years]
• Anti-drug Antibodies of SCTB35 [Срок оценки: Up to approximately 3 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Cancer Hospital — Пекин

Идентификаторы

NCT: NCT07570823 · SCTB35-B301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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