Efficacy and Safety of TC011 in Relapsed or Refractory Follicular Lymphoma

Официальное название

A Multi-center, Single-arm, Open-label Phase II Study to Evaluate the Efficacy and Safety of TC011 in Patients With Relapsed or Refractory Follicular Lymphoma

Обзор

This Phase II, multi-center, single-arm, open-label study evaluates the efficacy and safety of TC011, a CD19-targeted CAR-T cell therapy, in adult patients with relapsed or refractory follicular lymphoma (Grade 1, 2, or 3a). The primary endpoint is objective response rate (ORR) assessed by independent review using the Lugano 2014 classification.

Подробное описание

This is a multi-center, single-arm, open-label Phase II clinical trial designed to evaluate the efficacy and safety of TC011, a CD19-targeted chimeric antigen receptor T-cell (CAR-T) therapy, in adult patients with relapsed or refractory follicular lymphoma.

Eligible patients who meet all inclusion and exclusion criteria will undergo leukapheresis for the manufacture of TC011, followed by lymphodepleting chemotherapy and a single intravenous infusion of TC011. Patients will be followed according to the study schedule to assess efficacy and safety outcomes.

The primary efficacy endpoint is objective response rate assessed by independent review using standardized response criteria. Secondary endpoints include additional efficacy measures and safety evaluations. Exploratory assessments may include characterization of TC011-related cellular kinetics and biomarker analyses.

An independent Data Safety Monitoring Board will periodically review accumulated safety and efficacy data to ensure patient safety throughout the study.

Вмешательства

• Биопрепарат TC011 single-arm
  CD19-targeted chimeric antigen receptor T-cell therapy

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: Up to 96 weeks]

Вторичные конечные точки (8)

• Complete Response Rate (CRR) [Срок оценки: Up to 96 weeks]
• Disease Control Rate (DCR) [Срок оценки: Up to 96 weeks]
• Stable Disease Rate (SDR) [Срок оценки: Up to 96 weeks]
• Duration of Response (DOR) [Срок оценки: Up to 96 weeks]
• Time to Response (TTR) [Срок оценки: Up to 96 weeks]
• Progression-Free Survival (PFS) [Срок оценки: Up to 96 weeks]
• Overall Survival (OS) [Срок оценки: Up to 96 weeks]
• Incidence and severity of adverse events [Срок оценки: Up to 96 weeks]

Критерии участия

Критерии включения

• Ability to provide written informed consent.
• Age ≥19 years at the time of screening.
• Histologically confirmed follicular lymphoma Grade 1, 2, or 3a according to WHO 2017 classification.
• Relapsed or refractory disease after at least two prior systemic therapies including rituximab.
• ECOG performance status ≤2.
• Life expectancy ≥12 weeks.
• At least one measurable lesion (long diameter ≥1.5 cm).
• Adequate hepatic, renal, hematologic, pulmonary, and cardiac function.
• Eligible for leukapheresis and successful manufacture of TC011.
• Agreement to use effective contraception for at least 6 months after TC011 infusion.

Критерии исключения

• Histologic transformation to diffuse large B-cell lymphoma or follicular lymphoma Grade 3b.
• Unresolved ≥Grade 2 toxicity from prior anticancer therapy (excluding hematologic abnormalities).
• Active or prior malignancy within 2 years, except adequately treated non-melanoma skin cancer or carcinoma in situ.
• Clinically significant cardiovascular disease within 6 months prior to screening.
• Active central nervous system involvement by lymphoma.
• Active uncontrolled infection, including HBV, HCV, HIV, or syphilis (protocol-defined exceptions apply).
• Active autoimmune or inflammatory neurologic disease.
• Rapidly progressive disease requiring urgent therapy.
• Prior treatment with anti-CD19 therapy, adoptive T-cell therapy, gene therapy, or allogeneic stem cell transplantation.
• Major surgery within 4 weeks prior to screening.
• Use of investigational agents within 4 weeks prior to screening.
• Known hypersensitivity to components of TC011.
• Pregnant or breastfeeding women.

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: NCT07360288 · TC011_FL_201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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