Interventional Treatment of Ovarian Cancer With Cancer Antigen-specific Engineered Immune Effector T Lymphocytes (OC-EIEs)
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Safety of OC-EIEs 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, engineered immune effectors (OC-EIEs) in women.
详细描述
Ovarian cancer (OC) is a cancer that is derived from an ovary. The majority of OC arises from the epithelium (outer lining) of the ovary. In 2015, OC was found in 1.2 million women and resulted in 161,100 deaths worldwide. Among women, OC is the seventh-most common cancer and the eighth-most common cause of cancer death. Treatment for OC consists of surgery, chemotherapy, immunotherapy and radiotherapy. The kind of treatment depends on many factors, including the type of OC, its stage and grade, as well as the general health of the patient.
Adoptive immunotherapy with cytotoxic T lymphocytes (CTLs) reactive with tumor antigens has proven to be effective against many types of cancer. OC has been shown to be highly immunogenic and therefore may respond well to innovative antigen-specific immunotherapy. Here, through cancer antigen screening and careful target antigen evaluation, the investigation aims to evaluate the safety and efficacy of multiple infusions of OC antigen-specific, engineered immune effectors (EIEs) in patients with OC.
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 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 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).
- •Prior treatment of any adoptive T cell therapy.
- •Current or recent treatment (within the 14-day period prior to Day 0) with any immune suppressive 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
- •Subject infected with HCV (HCV antibody positive), or HIV (HIV antibody positive),Treponema pallidum antibody positive or TB culture positive.
研究组 & 干预措施
OC-EIEs
Autologous ovarian cancer antigen-specific cytotoxic lymphocytes
干预措施: OC-EIEs (Biological)
结局指标
主要结局
Safety of OC-EIEs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events
时间窗: 6 months
percentage of patients with grade 3 or above adverse effect
次要结局
- Expansion of OC-EIEs(8 weeks.)
- percentage of complete response(1 year)
- percentage of partial response(1 year)
- percentage of stable disease(1 year)
- percentage of progressive disease(1 year)
研究者
Lung-Ji Chang
President
Shenzhen Geno-Immune Medical Institute