NCT05533203招募中1 期
A Multicenter, Non-randomized, Open-label, and Dose-escalation Phase I Study to Evaluate the Safety of Prodencel Treatment in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC)
Shanghai Humantech Biotechnology Co. Ltd1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年8月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (AEs) during Induction Immunization
研究概览
简要总结
This phase I clinical trial is to evaluate the safety of Prodencel (an autologous dendritic cell therapeutic tumor vaccine.) in patients with metastatic castration-resistant prostate cancer (mCRPC).
详细描述
This is a single arm pilot study to evaluate the safety of delivering a dendritic cell vaccine in fifteen to twenty-four (n=15-24) adult patients diagnosed with prostate adenocarcinoma after novel androgen-deprived therapy and docetaxel chemotherapy failure. The study is constructed in a 3+3 design for three steps of dose escalation with rigorous and mandatory safety monitoring. Subjects received the vaccine at a dose of 5-15×10^6 cells every two weeks for a total of 3 doses. A dose from cohort 1-3 is recommended for booster immunization every 4 weeks until disease progression or intolerance, to evaluate the safety and tolerability of the booster immunization of Prodencel. Subjects will be monitored for adverse events as dictated by CTCAE version 5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically prostate adenocarcinoma, exclusion of the initially diagnosed neuroendocrine or small-cell carcinoma.
- •Subjects with metastatic castration-resistant prostate cancer (mCRPC) who have failed novel androgen-deprived therapy and docetaxel chemotherapy. The previous antitumor treatment is ≥4 weeks prior to first dose.
- •The previous clinical trials is ≥30 days prior to screening; Under the circumstance of previous clinical trials≤3 months , the pre-trial drug cannot interfere the safety and efficacy of current trial judged by the investigators.
- •Age ≥18 years old when signing ICF, male, weight ≥50kg.
- •Screening ECOG performance status is ≤
- •Written information consent provided prior to the initiation of study procedures with cooperation during the follow-up.
排除标准
- •Treatment requirement of Olaparib with the confirmed BRCA gene mutation.
- •Rechallenge of docetaxel or other chemotherapy.
- •Imminent Radiotherapy with radium-
- •Plan to participate in other clinical trials.
- •Pathological long bone fracture (cortical erosion > 50% on imaging) or spinal cord compression.
- •History of other malignancies in the past 5 years with the exception of the following：cancer disease free≥5 years or squamous or basal cell skin carcinoma.
- •Systemic therapy of immunosuppressive agents (such as cyclosporine, tacrolimus, rapamycin, and azathioprine, etc.) within one month prior to screening.
- •Use of oral, intramuscular or intravenous corticosteroids within 28 days prior to enrollment. Short-term use of corticosteroids are allowed to prevent reactions for imaging studies. Use of inhaled corticosteroids for breathing insufficiency (chronic obstructive pulmonary disease) and topical steroids are allowed.
- •Positive infectious disease screening. Active HBV hepatitis (defined as positive HBsAg with HBV-DNA ≥ upper limit of normal （ULN））; Active hepatitis C (defined as HBV-Ab ≥ULN)； Positive COVID-19；Human immunodeficiency virus (HIV) infection with HIV-Ab ≥ULN；Positive syphilis with TP-Ab≥ULN.
- •Myocardial infarction, unstable angina pectoris, cardiac surgery or interventional therapy within 6 months prior to enrollment. Congestive heart failure, atrial fibrillation or other poorly controlled arrhythmias.
- •Cerebrovascular events (including hemorrhagic, ischemic, transient ischemic attack), craniocerebral surgery and unexplained loss of consciousness occurred within 6 months before enrollment.
- •Presence of the malignant pleural effusion or malignant ascites.
- •History of severe allergic reactions or allergies to the ingredients of Prodencel.
- •Abnormal screening hematologic function: white blood cell count (WBC)<3.0×109/L, neutrophil count (NEUT)<1.5×10^9/L, platelet count (PLT)<100×10^9/L, hemoglobin (Hb)< 100g/L.
- •Abnormal screening coagulation function: prothrombin time (PT) ≥ULN, international normalized ratio (INR) ≥ULN, thrombin time (TT) ≥ULN.
- •Abnormal screening liver and kidney function: total bilirubin (TBIL) > 1.5ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5ULN; serum creatinine (SCr) > 1.5 ULN.
- •History of splenectomy.
- •Presence of primary or secondary immunodeficiency disease.
- •History of uncontrolled seizures, central nervous system disorders, or psychotic loss of cognition.
- •History of chronic alcohol or drug abuse within 6 months prior to screening.
- •Unstable systemic diseases, such as active infection, liver cirrhosis, chronic renal failure, severe chronic lung diseases, etc.
- •Clinically severe pericardial effusion.
- •Not suitable for leukapheresis.
- •For any other reasons, the patients are believed not suitable for participation in this study by investigators.
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (AEs) during Induction Immunization
时间窗: Up to 2 weeks after the third administration
AEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
次要结局
- Incidence of Treatment-Emergent Adverse Events (AEs) during Booster Immunization(Up to approximately 1 year)
研究者
研究点 (1)
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