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临床试验/jRCTc030210068
jRCTc030210068暂停不适用

WT1 peptide-pulsed dendritic cell therapy for wet age-related macular degeneration

未提供0 个研究点目标入组 10 人开始时间: 2021年11月25日最近更新:

试验速览

阶段
不适用
状态
暂停
入组人数
10
主要终点
-

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Single Arm Study
干预模型
Single Assignment
主要目的
Treatment Purpose
盲法
Open(masking Not Used)

入排标准

年龄范围
50age old over 至 No limit(—)
性别
All

入选标准

  • Clinically diagnosed with wet age-related macular degeneration
  • The name of the disease in 1) has been announced.
  • HLA type is HLA-A (A * 2402, A * 0201, A * 0206), HLA-DR (DRB1 * 0101, DRB1 * 0405, DRB1 * 0802, DRB1 * 0803, DRB1 * 0901, DRB1 * 1201, DRB1 * 1403, DRB1 * 1501, DRB1 * 1502, DRB5 * 0102), HLA-DP (DPB1 * 0201, DPB1 * 0202, DPB1 * 0402, DPB1 * 0501, DPB1 * 0901), HLA-DQ (DQB1 * 0301, One of DQB1 * 0302, DQB1 * 0401, DQB1 * 0501, DQB1 * 0601, DQB1 *
  • Outpatient visits are possible according to the research implementation schedule.
  • Patient without treatment for cancer.
  • Over 50 years of age
  • Patients who retain the functions of major organs (confirmed by pre-registration examination).
  • Written consent from the patient has been obtained for participation in this study.
  • Meet the apheresis eligibility criteria for dendritic cell production

排除标准

  • Have an uncontrolled infectious disease
  • Serious complications: malignant hypertension, severe congestive heart failure, severe coronary failure, unstable edema or myocardial infarction within 12 months, severe arrhythmia requiring medication and more than 2nd degree Patients with conduction abnormalities such as AV block, liver cirrhosis, uncontrolled diabetes, pulmonary fibrosis, interstitial pneumonia, marked peripheral edema, etc. active infections, active hepatitis B
  • Patients who are considered unsuitable for participation in this clinical trial due to complications or whose safety may be compromised due to serious medical events.
  • Cases in which antitumor treatment such as chemotherapy / radiochemotherapy was performed within 1 year
  • Have serious complications
  • Patients with myelodysplastic syndrome, myelodysplastic / myeloproliferative disorders and chronic myelogenous leukemia
  • History of severe drug hypersensitivity (excluding iodine contrast media)
  • Patients with severe mental illness
  • Patients with autoimmune disease
  • Patients with a history of allergies to OK-432 and penicillin G
  • Pregnant or lactating women
  • Pregnant women who are not willing to contracept

结局指标

主要结局

-

Safety(Adverse event rate,Rate of serious adverse events)

次要结局

  • Average change in best-corrected visual acuity
  • Amount of change in central retinal thickness
  • Amount of change in lesion area of choroidal neovascularization
  • Delayed hypersensitivity reaction to WT1 peptide
  • WT1-specific immunological monitoring
  • WT1 non-specific immune response

研究者

发起方
未提供

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