Phase I/II and Multicenter Trial of HPV Specific Immune Lymphocytes (HPV-CTLs) in the Treatment of Human Papilloma Virus (HPV) Infection
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Safety of HPV-CTLs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events
研究概览
简要总结
The purpose of this clinical trial is to evaluate the safety and efficacy of IV-infused autologous or allogenic HPV-CTLs.
详细描述
Human papilloma viruses (HPV) have been consistently implicated in causing cervical cancer especially those high-risk types (HPV 16, 18, 31, 45). Around 50-80% of women are infected by HPV within their whole lives. The current treatment of HPV-positive mainly includes drug, cryotherapy, laser, microwave, surgery and so on. Some treatments are convenient, but easy to cause pain or infection and there is still a greater risk of recurrence after treatment.
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 HPV specific cytotoxic T lymphocytes cells 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
- 6 Months 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written, informed consent obtained prior to any study-specific procedures.
- •Evidence of HPV virus activation (viral DNA) or high risk of HPV infection.
- •Not suitable for routine treatment or invalid to antiviral drugs.
- •Patients with viral disease symptoms and confirmed by biopsy, regardless of the level of virus DNA.
- •Age less than 75 years.
- •Did not use Penicillin or β-lactam antibiotics, or the lowest dose of other antibiotics.
- •Initial hematopoietic reconstitution: neutrophils (ANC) ≥ 1,000/mm^3, platelet (PLT) ≥ 1,000/mm^
- •Proper renal and hepatic functions (ULN denotes "upper limit of normal range"): Creatinine ≤ 2*ULN, Bilirubin ≤ 2*ULN, SGOT/ SGPT ≤ 3*ULN.
- •If HPV-CTL is not from the patient's own, then the provider of HPV-CTL needs to meet the following criteria:
- •did not receive chemotherapy or radiotherapy within 4 weeks prior to blood collection, and did not take any steroids for the previous week, did not use Penicillin or β-lactam antibiotics, or the lowest dose of other antibiotics.
- •white blood cells ≥ 3,500 / μl, lymphocytes ≥ 750 / μl.
- •Human immunodeficiency virus (HIV) test was negative.
排除标准
- •Subject or the donor of BMT recipient infected with HCV (HCV antibody positive), HBV (HBsAg positive), HIV (HIV antibody positive), HTLV (HTLV antibody positive), Treponema pallidum antibody positive or TB culture positive.
- •Subject is albumin-intolerant.
- •Subject with life expectancy less than 8 weeks.
- •Subject participated in other investigational somatic cell therapies within past 30 days.
- •Subject with positive pregnancy test result.
研究组 & 干预措施
HPV-CTLs
Autologous or allogenic HPV specific cytotoxic lymphocytes
干预措施: HPV-CTLs (Biological)
结局指标
主要结局
Safety of HPV-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
- Treatment Responses(1 year)
- Viral load response(6 months)
研究者
Lung-Ji Chang
President
Shenzhen Geno-Immune Medical Institute