JPRN-jRCTc051190054已完成1 期
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. - HiDCV-OS1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 4
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
- >= 20age old 至 <= 80age old（—）
- 性别
- Female
入选标准
- •Primary registration
- •1)Patients providing a written informed consent to participate in this clinical study by voluntary agreement based on her will.
- •2)Patients proving a written informed consent to use ovarian cancer tissue obtained by operation etc. for making the fusion cell.
- •3)Age over 20 and less than or equal to 80 years old at the time of informed consent
- •4)Have a diagnosis of ovarian carcinoma as confirmed by histology
- •5)Clinical stage III or IV by FIGO2014
- •6)No medical history of chemotherapy against ovarian cancer, and plan to have chemotherapy in the near future
- •7)ECOG Performance Status 0 or 1
- •8)The marrow function, liver function and the kidney function must be kept as follows at the screening visit
- •(1) leukocyte >=3,000/mcL
- •(2) platelet >= 130,000/mcL
- •(3) hemoglobin >= 8.0 g/dL.
- •(4) AST =< 100 IU/L
- •(5) ALT =< 100 IU/L
- •(6) total bilirubin =< 2.5 mg/dL
- •(7) serum creatinine =< 2.5 mg/dL
- •Secondary registration
- •1)Patients providing a written informed consent to have the HiDCV-OS1 Hybrid cell therapy by voluntary agreement based on her will.
- •2)Prepared HiDCV-OS-1 hybrid cells compatible with appropriateness criteria
- •3)Patients treated surgically for primary or metastatic lesion of ovarian cancer before or after the primary registration.
- •4)Patients treated with chemotherapy less than or equal to three regimens including the platinum drugs before the secondary registration, and following (1) or (2).
- •(1)Evaluated PD after previous chemotherapy
- •Evaluated SD, and medical doctor diagnosed that chemotherapy was difficult to continue due to severe adverse events.
- •Evaluated SD, and medical doctor diagnosed chemotherapy had no effect because of tumor progression.
- •(2)Patients had relapsed ovarian cancer recognized by imaging test within 6 months after chemotherapy
- •5)The marrow function, liver function and the kidney function must be kept as follows at the screening visit
- •(1) leukocyte >= 3,000/mcL
- •(2) neutrophil >= 1,500/mcL
- •(3) platelet >= 75,000/mcL
- •(4) hemoglobin >= 8.0 g/dL.
- •(5) AST=< 100 IU/L
- •(6) ALT =< 100 IU/L
- •(7) total bilirubin =< 2.5 mg/dL
- •(8) serum creatinine =< 2.5 mg/dL
- •6)ECOG Performance Status =< 2
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(%) =< 63% or APTT >= 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(%) =< 63% or APTT >= 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.
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