JPRN-jRCT2033200431
Recruiting
Phase 1
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 sites18 target enrollmentMarch 18, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with GPC3-expressing advanced ovarian clear cell carcinoma with peritoneal dissemination
- Sponsor
- Harano Kenichi
- Enrollment
- 18
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 1
Clinical trial of repeated intraperitoneal administration of GAIA-102 in patients with advanced gastrointestinal cancer (gastric cancer / pancreatic cancer) of microsatellite stable (MSS) with malignant ascites (Phase I / II Investigator-initiated clinical trial)Advanced gastrointestinal cancer of microsatellite stablegastric cancer, pancreatic cancerGastrointestinal NeoplasmsJPRN-jRCT2073220017Eiji Oki96
Completed
Phase 1
Phase I/II study of intravenous and intraperitoneal paclitaxel combined with continuous intraperitoneal cisplatin for advanced gastric cancer with peritoneal metastasisadvanced gastric cancer with peritoneal metastasisJPRN-UMIN000002257Department of Surgical Oncology, The University of Tokyo25
Completed
Not Applicable
Phase I/II study of intravenous and intraperitoneal paclitaxel for peritoneal metastasis after resection of pancreatic cancer refractory to gemcitabine and fluoropyrimidine chemotherapyPeritoneal metastasis after resection of pancreatic cancer refractory to gemcitabine and fluoropyrimidine chemotherapyJPRN-UMIN000016670Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine35
Recruiting
Not Applicable
The study on the efficacy of intraperitoneal administration of triamcinolone acetonide to cancerous ascites in end-of-life patientscancerJPRN-UMIN000034123Ashiya Municipal Hospital15
Not yet recruiting
Phase 1
Mesenchymal Stem Cell Therapy For Covid 19Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereCTRI/2020/08/027043eurogen Brain and Spine Institute