IMM0306 in Combination With Lenalidomide vs Placebo in Combination With Lenalidomide in Patients With Relapsed/Refractory Follicular Lymphoma

Официальное название

A Randomized, Double-Blind, Controlled, Multicenter, Phase III Clinical Study of IMM0306 (Amulirafusp Alfa) for Injection in Combination With Lenalidomide Versus Placebo in Combination With Lenalidomide in Patients With Relapsed/Refractory Follicular Lymphoma

Обзор

This study is a randomized, controlled, double-blind, multicenter, phase III clinical study to evaluate the efficacy of IMM0306 (Amulirafusp Alfa)in combination with lenalidomide versus placebo in combination with lenalidomide in patients with Relapsed/Refractory Follicular lymphoma. Primary endpoints are Complete Remission Rate (CRR) and Progression-Free Survival (PFS).

Вмешательства

• Препарат IMM0306 2.0 mg/kg
  IV infusion;
• Препарат Placebo
  IV infusion;
• Препарат Lenalidomide 20 mg
  orally

Первичные конечные точки

• Complete remission rate(CRR) as Assessed by Investigator [Срок оценки: approximately 48 months]
• Progression-Free Survival (PFS) as Assessed by Investigator [Срок оценки: approximately 48 months]

Вторичные конечные точки (7)

• Complete remission rate(CRR) as Assessed by Independent Review Committee(IRC) [Срок оценки: approximately 48 months]
• Progression-Free Survival (PFS) as Assessed by Independent Review Committee(IRC) [Срок оценки: approximately 48 months]
• Objective Response Rate (ORR) [Срок оценки: approximately 48 months]
• Duration of Response (DOR) [Срок оценки: approximately 48 months]
• Overall Survival (OS) [Срок оценки: approximately 60 months]
• Time to Next Anti-Lymphoma Treatment(TTNT) [Срок оценки: approximately 48 months]
• Adverse Event (AE) [Срок оценки: approximately 48 months]

Критерии участия

Критерии включения

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• At least one measurable lesion (as per Lugano 2014 criteria).
• Histologically confirmed CD20-positive Follicular Lymphoma, Grade 1, 2, or 3a.
• Previously received at least two prior systemic regimens, including at least one line containing an anti-CD20 monoclonal antibody.
• Adequate hepatic, hematologic, and renal function.
• Expected survival at least 6 months.

Критерии исключения

• Autologous HSCT within 100 days prior to first administration, or any prior allogeneic HSCT or solid organ transplantation.
• History of central nervous system (CNS) metastases or active CNS involvement.
• History of other malignancy within the past 5 years.
• Severe organic cardiovascular or cerebrovascular diseases.
• History of severe allergic reactions to any components of the trial drug, any macromolecular protein preparations or monoclonal antibodies.
• Previous treatment with anti-CD47 monoclonal antibody/SIRPα fusion protein.
• Human immunodeficiency virus (HIV) infection.
• Echocardiography examination indicating left ventricular ejection fraction (LVEF) < 55%.
• Active infection requiring systemic therapy (e.g., fungal, bacterial, viral).

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Cancer Hospital — Пекин

Идентификаторы

NCT: NCT07355283 · IMM0306-004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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