A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related

Официальное название

A Phase 1, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma

Обзор

This is a Phase I clinical study aimed to assess the safety, tolerability, and efficacy of SCG101 monotherapy for patients with HBV-HCC.

Вмешательства

• Биопрепарат SCG101
  Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels.

Первичные конечные точки

• Incidence of dose-limiting toxicity (DLT) and adverse events (AEs), including serious AEs (SAEs), cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS). [Срок оценки: Start of SCG101 infusion until disease progression or 12 months post infusion]
• The preliminary clinical efficacy of SCG101, including objective response rate (ORR), disease control rate (DCR), duration of response (DoR), time to response (TTR), progression-free survival (PFS), and overall survival (OS). [Срок оценки: Start of SCG101 infusion until disease progression or 12 months post infusion]
• Change in pharmacodynamics markers (PD) before and after SCG101 infusion [Срок оценки: Start of SCG101 infusion until disease progression, an average of 24 months]
• Persistences of viral vector copy number (VCN) after SCG101 infusion [Срок оценки: Start of SCG101 infusion until disease progression, an average of 24 months]

Критерии участия

Критерии включения

• Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)
• Subjects with HCC who have received standard systemic therapies
• HLA-A \*02
• BCLC stage B or C
• Child-pugh score ≤ 7 ol
• Serum HBeAg negative, serum (or tumor tissue) HBsAg positive, and serum HBV-DNA must be ≤ 1 × 1000 IU/ml
• Have at least one measurable leasion at baseline as per mRECIST and iRECIST
• Life expectancy of 3 months or greater
• The organ function is in good condition.

Критерии исключения

• Subjects with history of another primary cancer within 5 years
• Central nervous system metastasis and clinically significant central nervous system disease
• Previous or current coexistence of hepatic encephalopathy
• Currently present with symptomatic third space fluid accumulation
• Hypertension that is poorly controlled, as determined by researchers (i.e., arterial hypertension that remains uncontrolled despite standard treatment)
• Known history of neurological or mental disorder, including epilepsy or dementia
• Suffering from active autoimmune diseases, or other significant ongoing immune rejection based on pathology and clinical diagnosis
• Prior exposure to any cell therapy such as, but not limited to killer (NK) cells, cytokine-induced killer (CIK) cells, dendritic cells (DC), cytotoxic T lymphocytes (CTL), stem cell therapy
• Positive for HCV - RNA test or positive for HAV IgM antibody or positive for HDV IgM antibody; or there is current evidence indicating the presence of HEV infection
• Allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamide and fludarabine)
• Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation

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

Китай · 7 центров

• Beijing — Пекин
• Guangzhou — Гуанчжоу
• Zhengzhou — Чжэнчжоу
• Changchun — Changchun
• Shenyang — Шэньян
• Ji'nan — Ji'nan
• Shanghai — Шанхай

Идентификаторы

NCT: NCT06617000 · SCG-101-CR-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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