NCT04768608已完成1 期
Clinical Trial for the Safety and Efficacy of Non-viral PD1 Integrated Anti-PSMA Chimeric Antigen Receptor T Cells in the Treatment of Refractory Castrate-Resistant Prostate Cancer
Zhejiang University1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2021年12月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Incidence of toxicity graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events
研究概览
简要总结
PD1-PSMA-CART in Treating Patients With Castrate-Resistant Prostate Cancer
详细描述
Clinical trial for the safety and efficacy of Non-viral programmed cell death protein-1(PD1) integrated anti-prostate-specific-membrane-antigen(PSMA) chimeric antigen receptor T(CART) cells in the treatment of Refractory Castrate-Resistant Prostate Cancer(CRPC)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Fully understand and voluntarily sign informed consent.
- •Aged 18 to 75 years old.
- •Expected survival > 6 months.
- •CRPC patients:Serum testosterone reached castration level (<50ng/dl or<1.7nmol/L) and: prostate specific antigen (PSA) increased more than 50% at intervals of one week or three consecutive times, with PSA>2 ng/ml; or imaging scans revealed two or more new lesions or enlargement of soft tissue lesions that met the criteria for evaluating solid tumor response.
- •CRPC patients received abiraterone or chemotherapy for 3 months or more, and were ineffective or progressive (PSA continued to rise for 3 months, or bone scan/whole-body imaging showed local recurrence or new metastasis).
- •Immunohistochemical staining of repetitive biopsy tissues showed the expression of PSMA in tumor cells was more than 50%.
- •Eastern Cooperative Oncology Group (ECOG) score ≤
- •Virological examination was negative.
- •Hematological indexes: hemoglobin > 100 g/L, platelet count > 100×10^9/L, absolute neutrophil count > 1.5×10^9/L.
排除标准
- •Prior treatment with any CART therapy targeting any target.
- •Prior treatment with any PSMA targeting therapy.
- •Need steroid therapy, except physiological replacement therapy.
- •Prior treatment with any immunotherapy, including tumor vaccine therapy, radium-223, checkpoint inhibitors and others.
- •Subjects with severe mental disorders.
- •Subjects with other malignant tumors.
- •Subjects with severe cardiovascular diseases: a, New York Heart Association (NYHA) stage III or IV congestive heart failure; b, history of myocardial infarction or coronary artery bypass grafting (CABG) within 6 months; c, clinical significance of ventricular arrhythmia, or history of unexplained syncope, non-vasovagal or dehydration; d, history of severe non-ischemic cardiomyopathy; e, the left ventricular ejection fraction (left ventricular ejection fraction< 55%) was decreased by echocardiography or multiple gated acquisition scan (within 8 weeks before peripheral blood mononuclear cell (PBMC) collection), and abnormal interventricular septal thickness and atrioventricular size associated with myocardial amyloidosis.
- •Patients with ongoing or active infection.
- •Organ function: a, Alanine aminotransferase or Aspartate aminotransferase >2.5*Upper limit of normal (ULN); Creatine kinase>1.5*ULN; Creatine kinase isoenzyme >1.5*ULN; Troponin T >1.5*ULN; b, Total bilirubin >1.5*ULN; c, Partial prothrombin time or activated partial thromboplastin time or international standardized ratio > 1.5*ULN without anticoagulant treatment.
- •History of participation in other clinical studies within 3 months or treatment with any gene therapy product.
- •Intolerant or allergic to cyclophosphamide or fludarabine.
- •Subjects not appropriate to participate in this clinical study judged by investigators.
研究组 & 干预措施
PD1-PSMA-CART
Experimental
Patients undergo leukapheresis by receiving cyclophosphamide and fludarabine on days -6 to -4, and then receive PD1-PSMA-CART intravenous injection (IV) at split doses from day 0 on.
干预措施: PD1-PSMA-CART cells (Drug)
结局指标
主要结局
Incidence of toxicity graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events
时间窗: 28 days
All adverse events (AEs) will be listed and summarized. Summaries of laboratory data will include, at a minimum, treatment-emergent laboratory abnormalities. Summaries of AEs and laboratory abnormalities will be based on the All Treated analysis set.
次要结局
- Prostate specific antigen (PSA) response rate(180 days)
- Radiographic response rate by RECIST 1.1 & PCWG3(180 days)
- Number of persistent CART cells detected by Quantitative Real-time Polymerase Chain Reaction or flow cytometry(180 days)
研究者
Weijia Fang, MD
Professor
Zhejiang University
研究点 (1)
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