JS203 Combination Regimens in B-Cell Non-Hodgkin's Lymphoma

Обзор

To evaluate the preliminary efficacy of JS203 combined with standard regimens in patients with B-cell Non-Hodgkin's lymphoma

Вмешательства

• Препарат JS203 in combination with gemcitabine and oxaliplatin
  Gemcitabine and oxaliplatin 8 cycles (Q3W) and JS203 (21 days/cycle) Cycle 1 QW,Cycle 2 and therafter Q3W until progression or unacceptable toxicity.
• Препарат JS203 in combination with ifosfamide, carboplatin and etoposide
  Ifosfamide, carboplatin and etoposide, 3 cycles (Q3W) and JS203, Cycle 1 QW, Cycle 2 and therafter Q3W until trasnplant, progression or unacceptable toxicity.
• Препарат JS203 in combination with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone
  Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone 6 cycles (Q3W) and JS203, 8 cycles (21 days/cycle), Cycle 1 QW, Cycle 2 to Cycle 8 Q3W.
• Препарат JS203 combined with lenalidomide
  lenalidomide,12 cycles, Cycle 1(Q3W), Cycle 2 to Cycle 12 (Q4W) and JS203, 12 cycles, Cycle 1 (21 days/cycle) QW, Cycle 2 to Cycle 12 (28 days/cycle) Q4W.

Первичные конечные точки

• Objective response rate (ORR) [Срок оценки: up to approximately 15 months]

Вторичные конечные точки (10)

• complete response (CR) [Срок оценки: up to approximately 24 months]
• Duration of response (DoR) [Срок оценки: up to approximately 24 months]
• Duration of complete response (DoCR) [Срок оценки: up to approximately 24 months]
• Time to response (TTR) [Срок оценки: up to approximately 24 months]
• Progression-free survival (PFS) [Срок оценки: up to approximately 24 months]
• Overall survival (OS) [Срок оценки: up to approximately 24 months]
• Adverse events (AE) [Срок оценки: up to approximately 24 months]
• PK [Срок оценки: up to approximately 24 months]
• ADA [Срок оценки: up to approximately 24 months]
• NAb [Срок оценки: Up to approximately 24 months]

Критерии участия

Критерии включения

Patients must meet all of the following inclusion criteria to be enrolled：

• Age range: 18 to 80 years old (inclusive), both male and female are acceptable；
• ECOG: 0-2；
• B-cell non-Hodgkin's lymphoma expressing CD20 antigen that has been pathologically diagnosed；
• At least one measurable lesion meeting the criteria specified in the Lugano 2014 response assessment； Acceptable organ function at screening；

Критерии исключения

• A history of severe allergy to monoclonal antibody therapy (or recombinant antibody-related fusion protein)；
• Previously received CD20-CD3 bispecific antibody treatment；
• Previous allogeneic hematopoietic stem cell transplantation；
• Previous solid organ transplantation；
• History of autoimmune diseases；
• Patients with a history of macrophage activation syndrome (MAS)/ hemophagocytic lymphohistiocytosis (HLH)；
• Patients with a history of progressive multifocal leukoencephalopathy (PML)；
• A known or suspected history of CNS lymphoma (including primary or secondary)；
• There is pleural effusion, peritoneal effusion or pericardial effusion that requires treatment (such as puncture or drainage)；

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Cancer Hospital — Пекин

Идентификаторы

NCT: NCT07081022 · JS203-002-II-B-NHL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗