NCT04368182Unknown1 期
A Study of AFP Specific T Cell Receptor Transduced T Cells Injection in Unresectable Hepatocellular Carcinoma
Zhejiang University1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2020年4月13日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Safety of C-TCR055
研究概览
简要总结
A study that aimed to assess the safety and anti-tumor activity of C-TCR055 injection in unresectable HCC patients
详细描述
This study plans to enroll 5 patients to assess the safety of C-TCR055. Subjects who meet the eligibility criteria will receive a single dose of C-TCR055 injection, and will be followed up post treatment for safety monitoring. The follow up period will last 12 months.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide written informed consent.
- •Age 18-70 years old, male or female.
- •Patients must meet the following criteria:
- •a. Histologically confirmed HCC; b. Serum AFP > 200ng/mL; c. Child-Pugh score ≤ 6; d. BCLC stage B and stage C defined by Chinese Liver Cancer Guideline 2017; e. Systemic therapy failed for HCC: those who received standardized systemic treatment for unresectable HCC and subsequently relapsed/progressed, or were intolerable or unwilling to receive treatment. Front-line system treatment should be approved in China (Sorafenib, lenvastinib, platinum-containing chemotherapy, regofinil); f. Previous systemic therapy was discontinued at least 2 weeks before apheresis; g. Local treatment (including surgery, ablation, interventional therapy, local radiotherapy, etc.) must be completed at least 4 weeks before apheresis, and there is no unhealed wound.
- •Has at least 1 measurable lesion as defined per RECIST v1.1;
- •HLA-A 02:01 allele positive;
- •Liver AFP expression IHC tests
- •≥20% tumor cells positive, and ≤5% non-tumor tissue positive
- •serum AFP ≥400ng/ml, and ≤5% non-tumor tissue positive.
- •ECOG score ≤ 1;
- •Expected survival > 12 weeks
- •Left ventricular ejection fraction (LVEF) ≥ 50% (measured by echocardiography).
- •No active pulmonary infections, normal pulmonary function and oxygen saturation ≥ 92% on room air
- •Laboratory criteria:
- •Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
- •Platelets ≥ 60 x 10^9/L
- •Hemoglobin ≥ 90g/L
- •Serum total bilirubin ≤ 2 x ULN
- •Aspartate aminotransferase (AST) and alanine aminotransferase
- •Creatinine ≤ 1.5 x ULN 12.If patient has previous HBV infection, patient should receive antivirals treatment following treatment guidelines during study period, and the HBV DNA copies should below the detection limit at screening.
- •Female subjects in childbearing age, their serum or urine pregnancy test must be negative, all subjects must agree to take effective contraceptive measures during the trial
- •Agree to abstain from alcohol during the study period
- •No contraindications for apheresis
- •Apheresis was received by laboratory, and passed QC.
排除标准
- •Have a history of allergy to cellular products.
- •Subject has liver transplantation history.
- •tumor volume was greater than 70% of liver tissue
- •Main portal vein carcinoma thrombus
- •Medium to severe ascites
- •subjects received other anti-tumor systemic therapies which were not recommended in guidelines. Or subjects received immunocheckpoint inhibitors which were discontinued less than 6 weeks or 2 drug half-lives before apheresis.
- •Subject has other primary cancer except for the following: A. Non-melanoma cured by excision, such as basal cell skin cancer. B.Cured in situ cancers such as cervical cancer, bladder cancer or breast cancer
- •Significant clinical gastrointestinal bleeding within 4 weeks before treatment.
- •Subjects with bone metastasis or central nervous system metastasis, or with hepatic encephalopathy, epilepsy, cerebrovascular accident and other central nervous system involvement diseases.
- •Prior treatment with genetically modified T cell therapy or stem cell therapy.
- •Uncontrolled active infection. Preventive antibiotics, antiviral and antifungal are permitted.
- •Active hepatitis virus infection. HCV RNA positive.
- •Subjects with syphilis or other acquired, congenital immunodeficiency disorders, including, but not limited to, HIV infected persons, systemic lupus erythematosus, psoriasis, etc.
- •Heart insufficiency subjects of Grade III or IV according to NYHA classification criteria.
- •Subjects received systemic therapeutic steroid doses (except for the recent or current use of inhaled steroids) or other immunotherapy (such as interleukin-interferon, thymosin, etc.) within 2 weeks before Leukocyte apheresis
- •Subjects received radiotherapy within 6weeks before Leukocyte apheresis
- •Subjects who are pregnant, lactating, or pregnant within 6 months
- •Any other disease that may increase the risk of the subject or interfere with the results of the study.
研究组 & 干预措施
Treatment group
Experimental
Autologous C-TCR055 administered by intravenous (IV) infusion
干预措施: Autologous C-TCR055 (Biological)
结局指标
主要结局
Safety of C-TCR055
时间窗: start treatment to 12 months
Determine if treatment with C-TCR055 is safe through assessment of adverse events(AEs) and serious adverse
次要结局
- ORR(start treatment to 12 months)
- DCR(3 months and 6 months)
- DOR(12 months)
研究者
TingBo Liang
Professor
Zhejiang University
研究点 (1)
Loading locations...
相似试验
Unknown
1 期
AFP Specific T Cell Receptor Transduced T Cells Injection(C-TCR055) in Unresectable Hepatocellular CarcinomaHepatocellular CarcinomaNCT03971747Shanghai AbelZeta Ltd.9
招募中
早期 1 期
Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-ALLT-Acute Lymphoblastic LeukemiaNCT06633354Zhejiang University30
招募中
早期 1 期
Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-lymphomaT-lymphoblastic LymphomaNCT06633341Zhejiang University30
招募中
1 期
Safety and Efficacy of Anti-FcRL5 CAR-T Cell Therapy in Treating Relapsed and Refractory Multiple Myeloma (R/R MM)Multiple MyelomaNCT06196255Xuzhou Medical University20
招募中
1 期
Individualized Tumor Specific TCR- T Cells in the Treatment of Advanced Solid TumorsSolid TumorNCT03891706Guangzhou FineImmune Biotechnology Co., LTD.30