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.
- Conditions
- Ovarian cancer
- Registration Number
- JPRN-UMIN000031281
- Lead Sponsor
- Osaka University Graduate School of Medicine
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 6
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: Adverse events during the clinical trial
- Secondary Outcome Measures
Name Time Method Responsibility Induction of antitumor immunity Tumor marker Adverse events due to apheresis. Blood level of anti-HVJ-E antibody, and antinuclear antibody