Intervention of Ovarian Cancer Based on Engineered Immune Effectors (EIEs)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Safety of OC-CTLs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events
研究概览
简要总结
This is a single-arm, open-label, phase I/II trial to evaluate the safety and efficacy of ovarian cancer specific cytotoxic lymphocytes (OC-CTLs) in women.
详细描述
Ovarian cancer is a cancer that forms in or on an ovary. The majority of ovarian cancers arise from the epithelium (outer lining) of the ovary. In 2015 it was reported found in 1.2 million women and resulted in 161,100 deaths worldwide. Among women it is the seventh-most common cancer and the eighth-most common cause of death from cancer. Treatment for ovarian cancer consists of surgery, chemotherapy, immunotherapy and sometimes, radiotherapy. The kind of treatment depends on many factors, including the type of ovarian cancer, its stage and grade, as well as the general health of the patient.
Adoptive immunotherapy with cytotoxic T lymphocytes (CTLs) reactive with specific viral antigens has proven to be effective. Here, the investigators aim to evaluate the safety and efficacy of multiple infusions of ovarian cancer specific cytotoxic T lymphocytes in patients.
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
- 10 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written, informed consent obtained prior to any study-specific procedures.
- •Age older than 10 years.
- •Eastern Cooperative Oncology Group (ECOG) PS of 0 or
- •Expected survival ≥ 12 weeks.
- •Histologically confirmed and documented high risk International Federation of Gynecology and Obstetrics (FIGO): Stage II-IV.
- •Not pregnant, and on appropriate birth control if of childbearing potential.
- •Initial hematopoietic reconstitution with
- •neutrophils (ANC) ≥ 1,000/mm^3;
- •platelet (PLT) ≥ 100,000/mm^
- •Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with
- •serum creatinine ≤ 2×ULN;
- •serum bilirubin ≤ 2×ULN;
- •AST/ALT ≤ 2×ULN;
- •ALKP ≤ 5×ULN;
- •serum bilirubin. 2.0 is acceptable in the setting of known Gilbert's syndrome.
- •Human immunodeficiency virus (HIV) and Hepatitis C virus (HCV) test were negative.
排除标准
- •Patients with ovarian tumors with low malignant potential (i.e. borderline tumors);
- •Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure (prior, current or planned treatment).
- •Previous treatment of adoptive T cell therapy.
- •Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug
- •Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations).
- •Pregnant or lactating females.
- •Inadequate bone marrow function with
- •absolute neutrophil count < 1,000/mm^3;
- •platelet count < 100,000/mm^3;
- •Hb < 9 g/dL.
- •Inadequate liver and renal function with
- •serum (total) bilirubin > 1.5 x ULN;
- •AST & ALT > 2.5 x ULN (> 5 x ULN in patients with liver metastases);
- •alkaline phosphatase > 2.5 x ULN;
- •serum creatinine >2.0 mg/dl (> 177 μmol/L);
- •urine dipstick for protein uria should be < 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hour urine collection and must demonstrate < 1 g of protein/24 hr.
- •Serious active infection requiring i.v. antibiotics at during screening.
- •Subject infected with HCV (HCV antibody positive), HBV (HBsAg positive), and HIV (HIV antibody positive),Treponema pallidum antibody positive or TB culture positive.
研究组 & 干预措施
OC-CTLs
Autologous ovarian cancer specific cytotoxic lymphocytes
干预措施: OC-CTLs (Biological)
结局指标
主要结局
Safety of OC-CTLs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events
时间窗: 6 months
Physiological parameter (measuring cytokine response, fever, symptoms)
次要结局
- Functional analyses of OC-CTLs in vitro(4 weeks)
- Anti-tumor effects(1 year)
研究者
Lung-Ji Chang
President
Shenzhen Geno-Immune Medical Institute