JPRN-jRCT2033200431招募中1 期
A phase 1 clinical trial of intraperitoneal administration of GPC3-CAR expressing iPS cell-derived innate lymphoid/natural killer cells for patients with GPC3 positive advanced ovarian clear cell carcinoma with peritoneal dissemination
Harano Kenichi0 个研究点目标入组 18 人开始时间: 2021年3月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •1. 1st time registration
- •1) Histologically diagnosed advanced or metastatic ovarian clear cell carcinoma with radiographically confirmed peritoneal metastases irrespective of metastases in other organs.
- •2) Patients who have progressed after receiving standard treatments for ovarian cancer.
- •3) At least one measurable lesion as defined by RECIST ver.1.1, and/or non-target lesion such as the malignant ascites retention.
- •4) Tumor must be glypican-3-positive by immunohistochemistry.
- •5) Age at registration is of 20 years or older.
- •6) ECOG Performance status, 0-2.
- •7) HLA typing, HLA-A24 or HLA-B52.
- •8) Adequate organ function by laboratory parameters within 7 days prior to the enrollment.
- •9) A non-pregnant female. Female of childbearing potential who are negative in a pregnancy test within 7 days before enrollment. Patients should agree to use an adequate method of contraception in this study and in the future.
- •10) The patient survival is expected to be longer than 3 months after registration.
- •11) Patients who provided written informed consent to be subjects in this study.
- •2. 2nd time registration
- •1)-11) Patients met inclusion Criteria of 1st time registration.
- •12) Patients who was able to produce iCAR-ILC-N101 at least 0.5 x 10^6 cells/kg/dose based on weight at the time of apheresis.
排除标准
- •1. 1st time registration
- •1) Synchronous or metachronous (within 2 years) malignancies.
- •2) Patients who has or is suspected to have bacterial infection or virus infection.
- •3) Patients who require platelet or red blood cell transfusion within 14 days prior to the apheresis.
- •4) Severe cardiovascular disease.
- •5) Has concurrent interstitial lung disease/pneumonitis, or a history of (noninfectious) interstitial lung disease/pneumonitis that required treatment with steroids.
- •6) History of hypersensitivity reactions to biological ingredients.
- •7) Females who are pregnant or breastfeeding.
- •8) History of the therapy derived from induced pluripotent stem cells.
- •9) Has pericardial effusion, pleural effusion requiring any therapies.
- •10) Has a history of cerebral infarction, cerebral hemorrhage, or transient cerebral ischemia within 180 days prior to enrollment.
- •11) Has a history of deep vein thrombosis or pulmonary embolism.
- •12) Is receiving systemic corticosteroids therapy or systemic immunosuppressive therapy.
- •13) Has received a live vaccine within 28 days prior to enrollment.
- •14) Has active brain metastasis or a tumor causing spinal cord compression.
- •15) Patients who is considered to interfere with evaluation of the study therapy or safety or interpretation of study results.
- •2. 2nd time registration
- •1)-15) Patients met exclusion Criteria of 1st time registration.
- •16) Has received prior antitumor therapy (e.g., chemotherapy, molecular-targeted therapy, therapeutic antibody, endocrine therapy, immunotherapy, and investigational therapy) or other investigational drug after 1st time registration.
- •17) Has received radiotherapy after 1st time registration.
- •18) Has received surgery under general anesthesia within 28 days prior to 2nd time registration.
- •19) Is not eligible to enroll in the clinical trial based on the judgment by the Principal Investigator or Sub-investigator.
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