Open-label clinical study for safety and preliminary efficacy of HiDCV-OS1 Hybrid cell (dendritic and tumor fusion cells) and subsequent subcutaneous administration of GEN0101 in patients with recalcitrant residual or relapsed ovarian cancer after strict chemotherapy. - Phase I safety and preliminary efficacy study of HiDCV-OS1 and GEN0101 against the patients suffering from chemotherapy-resistant ovarian cancer.

Osaka University Graduate School of Medicine0 个研究点目标入组 6 人开始时间: 2018年2月13日最近更新: 2023年10月17日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Osaka University Graduate School of Medicine
入组人数: 6

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

one of grade >=3 TEAE whose causal relationship with the treatment cannot be ruled out were reported, and the treatment was indicated to some extent to be tolerable.In cytoreductive effects, there were no cases that could obtain CR or PR. However, the induction of tumor immunity and the reduction of tumor marker level were observed in some cases. Although the conclusive judgment may be impossible from such small cases, tumor immunity could possibly be induced by the protocol treatment in this study.

研究设计

研究类型: Interventional

入排标准

年龄范围: 20years-old 至 80years-old（—）
性别: Female

入选标准

未提供

排除标准

•Primary registration 1) Brain metastasis 2) Serious complications such as uncontrolled active infection 3) Medical history of other malignancy, except for the relapse-free and metastasis-free for more than 2 years after the last treatment at the registration 4) Active autoimmune disease 5) Receiving systemic administration of glucocorticosteroid which restrains immunity response except low dose of oral predonisone. 6) PT(%) less than 63% or APTT more than 58.5 sec at the screening visit 7) Positive result of the HCV antibody, HBV, HIV, or HTLV-I test at the screening visit 8) Inappropriate to be enrolled in this study judged by the investigators Secondary registration 1) Withdraw the agreement after the primary registration. 2) Positive for skin prick test of GEN0101. 3) Brain metastasis. 4) Other malignancy after the primary registration. 5) Serious complications such as uncontrolled active infection. 6) Receiving systemic administration of glucocorticosteroid which restrains immunity response except low dose of oral predonisone. 7) PT(%) less than 63% or APTT more than 58.5 sec at the screening visit. 8) Administered with unapproved drug within 4 weeks before the secondary registration. 9) Inappropriate to be enrolled in this study judged by the investigators.

研究者

发起方

Osaka University Graduate School of Medicine

相似试验

已完成

1 期

Phase I safety and preliminary efficacy study of HiDCV-OS1 and GEN0101 against the patients suffering from chemotherapy-resistant ovarian cancer.Ovarian cancer

JPRN-jRCTc051190054Kimura Tadashi4

进行中（未招募）

不适用

Primary vaccination course with the pneumococcal vaccine GSK 1024850A, in healthy infants in Vietnam when co-administered with GSK Biologicals’ Infanrix hexa™ (DTPa-HBV-IPV/Hib) vaccine.Healthy volunteers (for three-dose primary vaccination against Streptococcus pneumoniae in healthy infants between 6 to 12 weeks of age at the time of the first vaccination)MedDRA version: 18.0Level: LLTClassification code 10042197Term: Streptococcus pneumoniae septicaemiaSystem Organ Class: 100000004862MedDRA version: 18.0Level: LLTClassification code 10042195Term: Streptococcus pneumoniae pneumoniaSystem Organ Class: 100000004862MedDRA version: 18.0Level: LLTClassification code 10054642Term: Streptococcus pneumoniae septicemiaSystem Organ Class: 100000004862MedDRA version: 18.0Level: LLTClassification code 10035648Term: Pneumococcal pneumonia [Streptococcus pneumoniae pneumonia]System Organ Class: 100000004862

EUCTR2012-000162-38-Outside-EU/EEAGlaxoSmithKline Biologicals300

已完成

不适用

An Safety Study to evaluate the effectiveness of Kalimera hair oil on Human hair health for hair Growth, Hair Strength, Hair Lustrous and Dandruff preventio

CTRI/2019/05/019022BioVein Innovations Solutions Private Limited50

进行中（未招募）

3 期

A Safety Study for Previously Treated Vatiquinone (PTC743) Participants With Inherited Mitochondrial DiseaseInherited Mitochondrial Disease

JPRN-jRCT2011230045Vinay Penematsa10

招募中

1 期

CSL312_3003 Safety and Pharmacokinetic study in Subjects 2 to 11 Years of Age with Hereditary AngioedemaHereditary angioedema (HAE)MedDRA version: 20.0Level: PTClassification code: 10019860Term: Hereditary angioedema Class: 100000004850

CTIS2022-502386-13-00CSL Behring LLC20