NCT04615845终止1 期
An Open Label, Single-center, Phase 1 Study to Evaluate the Safety of Cancer Immunotherapy With Autologous Dendritic Cells in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Adverse Event
研究概览
简要总结
The goal of this clinical trial was to evaluate the safety of Cellgram-DC-PC, an autologous dendritic cell-based cancer immunotherapy, in patients with metastatic castration-resistant prostate cancer (mCRPC).
详细描述
Cellgram-DC-PC is an autologous dendritic cell-based cancer immunotherapy developed for patients with metastatic castration-resistant prostate cancer (mCRPC). This was a Phase 1, single-center, open-label clinical trial designed to characterize the safety profile of Cellgram-DC-PC following administration in patients with mCRPC.
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
盲法说明
This was an open-label study in which both investigators and participants were aware of the assigned intervention.
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •19 and under 80 years
- •Histologically confirmed prostate adenocarcinoma
- •Patients with stage M1a or M1b with extrapelvic lymph nodes and bone metastases
- •Patients diagnosed with castration-resistant prostate cancer after failure of male hormone deprivation therapy (Castrate levels of testosterone <50 ng/dL) and If either a or b is satisfied:
- •Biochemical progression: Prostate Specific Antigen (PSA) increases three times in a row at 1 week intervals, two 50% increases compared to the lowest point, PSA> 2ng/mL, or
- •Radiological progression: appearance of new lesions; 2 or more new lesions on the bone scan
- •Asymptomatic or mild patients after previous treatment
- •Patients who have not used narcotic analgesics within 21 days prior to enrollment
- •Patients with an average weekly pain of less than 4 on the Visual Analogue Scale(VAS) (out of 10)
- •Combination of Luteinizing hormone-releasing hormone(LHRH) analogs (leuprolide (Lupron, Viadur, Eligard) and goserelin (Zoladex, etc.) for the inhibition of gonadotropin is allowed
- •Whole body performance status: European Cooperative Oncology Group(ECOG) 0~1
- •Patients whose life expectancy is at least 6 months or longer
- •Hb ≥ 8.0g/dL, Absolute Neutrophil Count(ANC) ≥ 1,500/mm3, Platelets ≥ 100,000/mm3
- •Serum Creatinine ≤ 2.0 x Upper Limit of Normal(ULN) or Calculated Creatinine Clearance > 30mL/min
- •Total Bilirubin ≤ 1.5 x ULN or Direct bilirubin ≤ ULN, Aminotransferase (AST)/Alanine aminotransferase(ALT) <2.5 x ULN
- •Patients who did not receive surgery, radiation therapy, or immunotherapy within the last 6 weeks and recovered from side effects
- •Patients who agreed to use medically recognized contraceptive methods during the clinical trial participation period
- •Patients who voluntarily participated in clinical trials and signed the Informed Contents Form (ICF)
排除标准
- •Patients who have a local recurrence and are scheduled for local treatment.
- •Patients with malignant tumors other than non-melanoma skin cancer in the past 3 years
- •Patients with visceral metastases (metastases to the lungs, liver, adrenal glands, peritoneum, brain, etc.)
- •Patients who previously received anti-tumor immunotherapy (anti-PD1, anti-PDL1 or anti-PDL2, etc.) or participated in immunotherapy-related clinical trials
- •Patients with active autoimmune diseases requiring systemic immunosuppression treatment (e.g., immunosuppressants such as cyclosporin A or azathioprine or steroids for disease control)
- •Patients with medical conditions requiring continuous or intermittent administration of systemic steroids or immunosuppressants
- •Patients who received blood products (limited to whole blood products) within 4 weeks of screening criteria, or patients who received colony stimulating factors (Colony Stimulating Factor or recombinant Erythropoietin)
- •Patients with a history of organ or hematopoietic stem cell transplantation
- •Patients with acute or chronic infections requiring systemic treatment
- •Patients known to be infected with human immunodeficiency virus (HIV)/serum positive
- •Patients with active hepatitis A, B or C
- •Patients with untreated syphilis (Fluorescent Treponemal Antibody Absorption Test (FTA-ABS) Immunoglobulin M positive patients)
- •Patients expected to require therapeutic biotherapy or immunotherapy
- •Patients who received live virus vaccines (e.g. measles, mumps, rubella, chickenpox, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), oral typhoid vaccine, Flu-Mist, etc.) within 30 days
- •Patients with a history of anaphylaxis to gentamicin
- •Others, if the person in charge of the study determines that it is not suitable for the clinical trial
研究组 & 干预措施
Cellgram-DC-PC
Experimental
Participants received Cellgram-DC-PC by subcutaneous injection near the inguinal lymph nodes.
干预措施: Cellgram-DC-PC (Biological)
结局指标
主要结局
Adverse Event
时间窗: From informed consent to the end of treatment at Week 28.
Adverse events (AEs) were assessed for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
次要结局
- Immune Response(At baseline (Week 0), Week 4, Week 8, Week 16, and Week 28.)
- Change in Prostate-Specific Antigen (PSA)(At baseline (Week 0), Week 2, Week 4, Week 8, Week 16, and Week 28.)
研究者
研究点 (1)
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