NCT04614051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 Advanced or Recurrent Epithelial Ovarian Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- The Measure CTCAE of Safety
研究概览
简要总结
The goal of this clinical trial was to evaluate the safety of Cellgram-DC, an autologous dendritic cell-based cancer immunotherapy, in patients with advanced or recurrent epithelial ovarian cancer.
详细描述
Cellgram-DC is an autologous dendritic cell-based cancer immunotherapy developed for patients with advanced or recurrent epithelial ovarian cancer. This was a Phase 1, single-center, open-label clinical trial designed to characterize the safety profile of Cellgram-DC following administration.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •19 and under 80 years
- •Patients with Fédération Internationale de Gynécologie et d' Obstétrique(FIGO) stage III with histologically confirmed advanced or recurrent epithelial ovarian cancer (Serous, endometrioid, and mucinous only), fallopian tube cancer, and primary peritoneal cancer (residual tumor size <1cm)
- •Patients who have undergone tumor reduction or staging and complete or plan to complete platinum-based chemotherapy
- •In case of complete or partial response in primary or secondary chemotherapy
- •Whole body performance status: European Cooperative Oncology Group(ECOG) 0~1
- •Patients whose BRCA gene mutation test results can be confirmed
- •Patients whose life expectancy is at least 6 months or longer
- •Hb ≥ 8.0 g/dL, Absolute Neutrophil Count(ANC) ≥ 1,500/mm3, Platelets ≥ 100,000/mm3
- •Serum Creatinine ≤ 1.5 x Upper Limit of Normal(ULN) or Serum Creatinine> 1.5 x ULN and Calculated Creatinine Clearance> 30 mL/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 a medically recognized contraceptive method (diaphragm method used with spermicide, abstinence) during participation in the clinical trial (injection or implantable hormone therapy is not appropriate).
- •Patients who voluntarily participated in clinical trials and signed the Informed Contents Form (ICF)
排除标准
- •Patients with malignant tumors other than non-melanoma skin cancer in the past 3 years
- •Patients with brain metastases
- •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 who use or plan to use Poly (ADP-ribose) polymerase (PARP) inhibitors due to the confirmed Breast Cancer Susceptibility Gene(BRCA) 1 or BRCA 2 mutation
- •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
- •Patients expected to need systemic chemotherapy, biotherapy, or immunotherapy for therapeutic purposes
- •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
- •Pregnant or breastfeeding patients
- •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
Experimental
Participants received Cellgram-DC by subcutaneous injection near the right or left axillary lymph nodes every 2 weeks for a total of 3 doses.
干预措施: Cellgram-DC (Biological)
结局指标
主要结局
The Measure CTCAE of Safety
时间窗: -5, -3, 0, 2, 4, 8, 16 and 28 weeks
The level of Adverse Event (AE) is described in accordance with the Common Terminology Criteria for Adverse Event (CTCAE) (Version 5.0).
Adverse Events
时间窗: From enrollment to the end of treatment at Week 28.
Adverse events (AEs) were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
次要结局
- Immune response evaluation (INF-r)(0, 2, 8, 16 and 28 weeks)
- Measurement of changes in tumor marker test results (CA-125)(0, 2, 4, 8, 16 and 28 weeks)
- Immune response evaluation (IL-12)(0, 2, 8, 16 and 28 weeks)
- Evaluation of solid tumor reflection at the time of follow-up observation(8 and 28 weeks)
- Immune Response(At baseline, Week 4, Week 8, Week 16, and Week 28.)
- Change in CA-125(At baseline, Week 2, Week 4, Week 8, Week 16, and Week 28.)
- Tumor Response by RECIST 1.1(At Week 8 and Week 28.)
研究者
研究点 (2)
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