Study of Anti-PSMA CAR NK Cell in Castration-Resistant Prostate Cancer
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Allife Medical Science and Technology Co., Ltd.
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| 追踪信息 | |||
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| 首次提交日期 ICMJE | September 29, 2018 | ||
| 首次发布日期e ICMJE | October 2, 2018 | ||
| 最后更新发布日期 | October 2, 2018 | ||
| 预计研究开始日期 ICMJE | December 2018 | ||
| 预计主要完成日期 | December 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Occurrence of treatment related adverse events as assessed by CTCAE v4.0[ Time Frame: Day 3-Year 2 after injection ] Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Study of Anti-PSMA CAR NK Cell in Castration-Resistant Prostate Cancer | ||
| 正式标题 ICMJE | Clinical Study on the Safety and Efficacy of Anti-PSMA CAR Car NK Cells in Castration-resistant Prostate Cancer (CRPC) | ||
| 简要概况 | This is a single centre、single arm、open-label，to investigate the safety and efficacy of anti-PSMA CAR NK cells in patients with castration-resistant prostate cancer. |
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| 详细说明 | This is a Phase I study evaluating the safety and feasibility of anti-PSMA CAR NK cells in a 3+3 dose escalation design. The Cohort subjects (N=3 or 6) will receive a single dose of 0.5-3 x 107/kg anti-PSMA CAR NK cells on day 0, following a single dose of 60mg/kg of cyclophosphamide administered up to 6-7 days prior to the CAR NK cells. If the number of manufactured CAR NK cells does not meet the pre-specified minimum infused dose of 1 x 107/kg cells, then dose will not be administered, and the subject will be replaced in the study. If 1 DLT/3 subjects occurs, the study will enroll an additional 3 subjects at this dose level. If 0 DLT/3 subjects or 1 DLT/6 subjects occurs, the study will advance to Cohort 2. If 2 DLT/3 subjects occurs at dose of 1-3 x 107/kg cells, then enrollment in this Cohort will be stopped.The members of Committee on Safety of Drugs will be evaluate safety,and the dose will be de-escalated | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Early Phase 1 | ||
| 研究设计 ICMJE | 分配: 干预模型: Sequential Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
9 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | December 2021 | ||
| 预计主要完成日期 | December 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: 1. Castration-Resistant Prostate Cancer, as defined by： Serum testosterone<50ng/dl or <1.7nmol/L. Increase in serum PSA of at least 25% and an absolute increase of 2ng/ml or more from nadir for at least three weeks. 2. Castration-Resistant Prostate Cancer≥10% tumor cells expressing PSMA as demonstrated by immunohistochemistry analysis on fresh tissue. 3. Patients > 18 years of age 4. ECOG performance status of 0 - 1 5. Adequate organ function, as defined by: Serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 60 cc/min Serum total bilirubin < 1.5x ULN Serum ALT/AST < 2x ULN 6. Adequate hematologic reserve within 4 weeks of study enrollment as defined by: Hgb > 10 g/dl PLT > 100 k/ul ANC > 1.5 k/ul Note: Subjects must not be transfusion dependent 7. Prior therapy with at least one standard 17α lyase inhibitor or second-generation anti-androgen therapy for the treatment of metastatic castrate resistant prostate cancer 8. Provides written informed consent 9. Subjects of reproductive potential must agree to use acceptable birth control methods Exclusion Criteria: 1. Prior treatment with an immune-based therapy for the treatment of prostate cancer, including cancer vaccine therapies (such as SipuleucelT, PROSTVAC), immune checkpoint inhibitors,radium-223 and immunoconjugate therapies. 2. History of an active non-curative non-prostate primary malignancy within the prior 5 years 3. Subjects with a rising PSA, but who have never had radiologic evidence of metastatic disease(i.e. 'biochemical recurrence') 4. Subjects who require the chronic use of systemic corticosteroid therapy 5. Subjects who have received > 3 prior therapies for the treatment of castrate resistant prostate cancer (excluding luteinizing hormone-releasing hormone agonists or antagonists, or first generation anti-androgen therapies). This includes subjects who received Taxotere in noncastrate setting. 6. Subjects with Class III/IV cardiovascular disability according to the New York Heart Association Classification 7. Subjects with symptomatic vertebral metastases affecting spinal cord function (as determined by clinical history, physical exam, or MRI imaging) 8. History of active autoimmune disease requiring immunosuppressive therapy 9. Patients with serious infection. 10. History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO) 11. Active hepatitis B (HBV DNA＞1000copy/mL), hepatitis C or HIV infection. 12. history of definite neurological or psychiatric disorders, including epilepsy or dementia. 13. Subjects with drug abuse,alcohol dependence,psychological or social conditions may interfere with the study or evaluate the results of the study. 14. Subjects who have other conditions that were not appropriate for the group determined by the researchers. | ||
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| 年龄 | 最小年龄：18 Years ，最大年龄：70 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | ||
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Allife Medical Science and Technology Co., Ltd. | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | September 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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