NCT04518774Unknown早期 1 期
The Safety Assessment of Ex-Vivo Expanded Allogeneic γδT Cells in Hepatocellular Carcinoma Patients in Phase 1 Clinical Trial
Beijing 302 Hospital3 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2020年8月15日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 8
- 试验地点
- 3
- 主要终点
- Safety evaluation: Dose limited toxicity (DLTs)
研究概览
简要总结
This study aims to evaluate the safety, tolerability and efficacy of ex-vivo expanded allogeneic γδT cells obtained from a blood-related donor of hepatocellular carcinoma patients.
详细描述
This study is a single-center, non-randomized, open label, no control, prospective clinical trial to evaluate the safety, tolerability and efficacy of ex-vivo expanded allogeneic γδT cells from of a blood-related donor of Hepatocellular Carcinoma (HCC) Patients. This study will include the following sequential phases: sign informed consent, γδT cell pre-culture, screening and registration to the trial, apheresis, γδT cell preparation, treatments and follow-ups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Inclusion Criteria:
- •Patients should sign informed consent form voluntarily before the trail and comply with the requirements of this study.
- •Age 18 years up to the age of 65 (≤65), gender unlimited.
- •Hepatocellular Carcinoma diagnosed according to the 2018 edition of the EASL guidelines. Patients should accept liver biopsy voluntarily and histopathologically diagnosed with HCC.
- •Interventional therapy (e.g. TACE), RFA or radiation therapy should be at least 2 weeks prior to γδT cell transfusion; surgical treatment should be at least 1 month prior to γδT cell transfusion. Patients can take the first- or second-line targeted drugs recommended by the guidelines, such as lenvatinib or sorafenib.
- •Liver function: Child-Pugh class A/B (5-9)
- •Eastern Cooperative Oncology Group (ECOG) Performance score≤
- •Life expectancy of at least 1 year.
- •Patients combined with HBV infection require antiviral treatment with nucleoside analogues; patients combined with HCV infection require direct-acting antiviral agent (DAA) treatment.
- •Male and female patients of reproductive potential must agree to use birth control during the study and for at least 30 days post study.
排除标准
- •Patients combined with HAV, HEV, HIV or other infectious diseases.
- •Acute infections, gastrointestinal bleeding, etc. occurred within 30 days before screening.
- •Women who are pregnant (urine/blood pregnancy test positive) or lactating; patients with severe autoimmune diseases; patients with uncontrolled infectious diseases.
- •Major organs dysfunction:
- •Peripheral blood: WBC<1.0×109/L, PLT <60×109/L, Hb <86g/L;
- •Coagulation: INR>2.3, PT>18s;
- •Liver function: ALB<28g/L, TBIL>51mmol/L, ALT/AST>5 times the upper limit of normal, CREA>1.5 times the upper limit of normal.
- •Combined with other severe organic diseases or mental illnesses, including any uncontrolled clinically significant systematic diseases such as urinary, circulatory, respiratory, neurological, psychiatric, digestive, endocrine and immune diseases.
- •Allergic constitution, history of allergies to blood products, known to be allergic to test substances.
- •Immunosuppressive or systemic cytotoxic drugs may require within 6 months prior to screening or during the study; 6 months prior to screening accepted other cell therapies including NK, CIK, DC, CTL and stem cell therapy etc.; immunotherapy such as PD-1 and PD-L1 antibodies.
- •Patients currently participating in other clinical trials who may violate this treatment plan and observations.
- •Those who are unable or unwilling to provide informed consent or who are unable to comply with the research requirements.
- •Any situation that investigators believe the risk of the subjects is increased or results of the trial are disturbed: patients with any serious acute or chronic physical or mental illness, or laboratory abnormalities.
- •Donor Inclusion Criteria:
- •Sign informed consent form.
- •Age 18 years up to the age of 50 (≤50), gender unlimited.
- •Relative to patients (unrestricted to blood relationship).
- •Apheresis available.
- •PLT≥100×109/L with normal APTT or PT.
- •Donor Exclusion Criteria:
- •History of any severe clinical diseases or other severe organic diseases, including any history of clinically significant systematic diseases such as cardiovascular, urinary, circulatory, respiratory, neurological, psychiatric, digestive and endocrine diseases. History of high blood pressure or systolic pressure>140 mmHg, diastolic pressure>90 mmHg in screening stage. Any situation that investigators believe is clinically significant or with other severe diseases unsuitable of apheresis.
- •Arterial thrombosis or venous thrombosis history 12 months prior to the trial or hemorrhagic tendency or history 2 months prior to the trial; oral administration of anticoagulation drugs (e. g. aspirin and warfarin).
- •Active or history of autoimmune diseases including but not restricted to SLE, psoriasis, RA, IBD and HT. Apart from hypothyrosis which can be controlled by hormone replacement therapy, skin diseases without systemic therapy and celiac disease which is fully controlled.
- •HIV-Ab, TP-Ab, HCV-Ab, HBsAg, HBeAg, HBeAb or HBcAb positive.
- •Any symptom, sign or laboratory examination abnormality suggesting acute or subacute infection (e.g. fever, cough, urinary irritation, skin infectious wound).
- •Female who are pregnant or cannot stop lactating.
- •Those who cannot communicate with medical staff due to mental illness or language disabilities.
- •Other unsuitable conditions that investigators believe unsuitable for the donation.
结局指标
主要结局
Safety evaluation: Dose limited toxicity (DLTs)
时间窗: up to 48 weeks
The incidence, characteristic and severity of DLTs will be recorded and assessed.
Safety evaluation: Maximum-tolerated dose (MTD)
时间窗: up to 48 weeks
MTD or clinical recommended dose will be recorded and evaluated.
Safety evaluation: Incidence of Adverse events (AEs)
时间窗: up to 48 weeks
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
次要结局
- Efficacy evaluation: Tumor markers(up to 48 weeks)
- Efficacy evaluation: γδT cells in peripheral blood(up to 48 weeks)
- Efficacy evaluation: Quality of life by ECOG score(up to 48 weeks)
研究者
研究点 (3)
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