A Multicenter, Single-Arm, Open-Label, Phase II Trial of Mosunetuzumab in Combination With Tislelizumab for r/r FL

Официальное название

A Multicenter, Single-Arm, Open-Label, Phase II Trial of Mosunetuzumab in Combination With Tislelizumab for Relapsed/Refractory Follicular Lymphoma (r/r FL)

Обзор

This is a multicenter, single-arm, open-label, investigator-initiated, phase II clinical trial designed to evaluate the feasibility, efficacy, and safety of Mosunetuzumab in combination with Tislelizumab in patients with relapsed/refractory follicular lymphoma (r/r FL).

Подробное описание

The study aims to enroll approximately 22 adult patients who have received at least two prior systemic therapies, including anti-CD20 monoclonal antibody treatment. The primary endpoint is the complete response rate (CR), while secondary endpoints include objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety assessment. The trial will be conducted at multiple centers in China, with an estimated study duration from May 2025 to May 2027.

Вмешательства

• Препарат Mosunetuzumab
  * Cycle 1: Day 1: 1 mg; Day 8: 2 mg; Day 15: 30 mg * Cycles 2-8: 30 mg every 3 weeks * Cycles 9-17: 30 mg every 3 weeks (if applicable） A treatment cycle is 21 days. Patients achieving complete remission (CR) by cycle 8 will stop treatment, while those with partial response (PR) or stable disease (SD) may continue up to 17 cycles or until disease progression or intolerable toxicity occurs.
• Препарат Tislelizumab
  \- Cycles 2-8: 200 mg IV every 3 weeks

Первичные конечные точки

• best of complete response rate (CR) [Срок оценки: up to the end of 8/17 cycles of treatment(each cycle 21 days)]

Вторичные конечные точки (4)

• Overall Response Rate (ORR) [Срок оценки: up to the end of 8/17 cycles of treatment(each cycle 21 days)]
• Duration of Response (DoR) [Срок оценки: up to 2 years]
• Progression-free survival (PFS) [Срок оценки: Assessed every 3 months during follow-up, up to 2 years]
• OS [Срок оценки: Assessed every 3 months during follow-up, up to 2 years]

Критерии участия

Критерии включения

• Signed written informed consent.
• Age ≥18 years.
• Histologically confirmed relapsed/refractory follicular lymphoma (r/r FL).
• Received at least two prior systemic therapies, including anti-CD20 monoclonal antibody therapy.
• ECOG performance status 0-1.
• Expected survival ≥12 weeks.
• Measurable disease (longest diameter >1.5 cm).
• Adequate organ function:

• Hepatic function: Total bilirubin ≤1.5×ULN; AST/ALT ≤3×ULN.
• Hematologic function: ANC ≥1.5 × 10⁹/L; Platelets ≥75,000/μL; Hemoglobin ≥10.0 g/dL.
• Renal function: Serum creatinine ≤1.5×ULN or CrCl ≥50 mL/min (Cockcroft-Gault formula).
• Women of childbearing potential must have a negative serum pregnancy test and agree to use contraception.

Критерии исключения

• Inability to comply with study hospitalization and restrictions.
• Active infections (including tuberculosis) or immunocompromised status.
• Prior history of severe hypersensitivity to similar agents.
• CNS involvement of lymphoma.
• Pregnant or breastfeeding women.
• Uncontrolled comorbid conditions, including cardiovascular or autoimmune diseases.
• Receipt of live attenuated vaccines within 4 weeks before enrollment.
• Use of systemic immunosuppressants within 2 weeks prior to first dose.
• History of drug or alcohol abuse in the past 12 months.
• Any condition deemed inappropriate for study participation by the investigator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07031700 · FL-RR-MOS01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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