NCT01265368已完成1 期
A Phase 1/2, Proof-of-Principle, Multi-Center, Open-Label, Single-Arm, Non-randomized Clinical Study to Assess Safety and Efficacy of a Tumor Vaccine Consisting of Genetically Modified Allogeneic (Human) Tumor Cells for the Expression of IL-7, GM-CSF, CD80 and CD154, in Fixed Combination With a DNA-based Double Stem Loop Immunomodulator in Patients With Advanced Renal Cell Carcinoma (ASET Study)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mologen AG
- 入组人数
- 19
- 试验地点
- 6
- 主要终点
- Assessment of safety profile of MGN1601
研究概览
简要总结
This is a Phase 1/2, proof-of-principle clinical study to assess safety and efficacy of a intradermally administered tumor vaccine (MGN1601). The study will be conducted in patients with advanced renal cell carcinoma.
详细描述
Twenty four patients with advanced RCC will be included in this open, single-arm study.
The treatment will last 12 weeks. The investigational product (MGN1601) will be administered intradermally for a total of 8 applications, whereas the first 3 applications will be administered weekly, and the following 5 applications will be administered bi-weekly.
Patients who will develop disease control (CR, PR, or SD) by week 12 will be proposed to participate in the extension phase of the study. The extension phase will be continued until disease progression in each patient, however, maximally up to week 120 (total treatment duration 2.5 years). During this time period the investigational product will be administered 5 times by weeks 24, 36, 48, 72, and 120.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects older than 18 years of age
- •Histologically confirmed renal cell carcinoma
- •Radiologically confirmed advanced disease defined as unresectable locally reccurrent or metastatic disease (AJCC Stage IV)
- •Previous nephrectomy
- •No standard therapy is available for the patient
- •At least 4 weeks after previous radiotherapy prior to study treatment
- •At least 1 week after previous systemic therapy prior to study treatment
- •At least one lesion measurable by modified RECIST criteria
- •ECOG performance status 0-1
- •Adequate organ function including hematopoietic organs
- •MSKCC prognostic ctiteria < 3 predictors of short survival
- •Negative urine pregnancy test in women with childbearing potential
- •Women of childbearing potential and all male participants are willing to use acceptable methods of contraception (birth control pills, barriers)
- •Expected adequacy of follow-up
- •Signed informed consent form (ICF).
排除标准
- •Clinically significant concomitant diseases or conditions unrelated to the underlying malignancy or therapy, which in opinion of the investigator would lead to an unacceptable risk for the subject to participate in the study
- •Known hypersensitivity to any component of the study drug
- •Prior or current other malignancy, except adequately treated superficial bladder cancer, basal or squamous cell carcinoma of the skin or other cancer for which the subject has been disease free for more than 3 years
- •Active brain metastases except adequately treated brain metastases with no progression for at least 3 months
- •Active or uncontrolled infections
- •Transfusion-dependent anemia
- •History of autoimmune disease or immune deficiency
- •Concurrent chronic systemic immune therapy, corticosteroids or other immunosuppressant medication
- •Concurrent radiotherapy within the last 4 weeks prior to study treatment and/or during the course of the study
- •Concurrent immunotherapy or targeted therapy within the last 1 week prior to study treatment and/or during the course of the study
- •HIV seropositivity or active hepatitis B or C infection
- •Planned major surgery during the study
- •Participation in other clinical studies during this clinical study
- •Vaccination within 3 months prior to the first treatment day
- •Any medical, mental, psychological or psychiatric condition which in opinion of the investigator would not permit the subject to complete the study or understand the patient information
- •Pregnancy and/or nursing
- •Presence of drug and/or alcohol abuse
- •Commitment to an institution by virtue of an order issued either by judicial or administrative authorities.
研究组 & 干预措施
Study medication
Experimental
干预措施: MGN1601 (Biological)
结局指标
主要结局
Assessment of safety profile of MGN1601
时间窗: Treatment phase (12 weeks), extension phase (120 weeks, if applicable), plus 5 years follow-up
次要结局
- Assessment of the presence of MIDGE vectors(Treatment phase (12 weeks))
- Evaluation of clinical and radiological response to MGN1601(Treatment phase (12 weeks), extension phase (120 weeks, if applicable) plus 5 years follow-up)
- Assessment of potential autoimmune effects of MGN1601(Treatment phase (12 weeks), extension phase (120 weeks, if applicable) plus 5 years follow-up (if applicable))
- Assessment of the immune response to MGN1601(Treatment phase (12 weeks), extension phase (120 weeks, if applicable))
研究者
研究点 (6)
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