跳至主要内容
临床试验/NCT04599426
NCT04599426Unknown1 期

Safety and Efficacy of Allogenic NK Cell Transfusion Combined With Azacitidine Therapy for the MDS-EB

The Second Hospital of Shandong University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
1 期
入组人数
10
试验地点
1
主要终点
Objective Response Rate (ORR) (PR+CR)

研究概览

简要总结

The aim of this investigation was to assess safety and efficacy of allogenic NK cells therapy for refractory MDS-EB.

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
15 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with refractory high-risk MDS (MDS-EB1 and EB2) who had no effect of 2 courses of desitabine or CAG or desitabine + CAG.
  • Patients with age 15 years to 70 years.
  • KPS greater than or equal to
  • ALT and AST are less than 3 times normal.
  • Total bilirubin less than 1.5mg/dl(25.65umol/L).
  • Serum creatinine less than 2.5mg/dl(221umol/L), or creatinine scavenging ability greater than or equal to 60 mL/min/1.73 m
  • Left ventricular ejection fraction cardiac greater than or equal to 45%, Echocardiography (ECHO) showed no pericardial effusion, Electrocardiogram (ECG) is normal.
  • No pleural effusion in lungs.
  • Oxyhemoglobin saturation greater than or equal to 92% in normal environment.
  • Women of child-bearing age have negative urine pregnancy tests before administration began, and agree to use effective contraception during the trial period up to the last follow-up.
  • KIR mismatch between patient and umbilical cord blood.
  • Volunteer to participate in the trial and sign the informed consent form.

排除标准

  • Malignant tumor patient.
  • Patients who are accompanied by fungal, bacterial, viral, or other uncontrolled infections or require level 4 isolation. (HBV-DNA quantification and normal liver function in patients with hepatitis b infection are excluded).
  • Patients with HIV, HCV positive.
  • Patients with central nervous system diseases, including stroke, epilepsy, dementia, or autoimmune central nervous system disorders.
  • Patients with central nervous system diseases, including stroke, epilepsy, dementia, or autoimmune central nervous system disorders.
  • Patients receiving anticoagulant therapy or with severe coagulation disorders.
  • According to the researcher's judgment, the drug treatment the patient is receiving will affect the safety and effectiveness of the study.
  • Patients with allergies or history of allergies to biological agents used in this program.
  • Lactating or pregnant women.
  • Systemic steroid used within 2 weeks before treatment (except for recent or present use of inhaled corticosteroids).
  • Patients with other uncontrolled diseases, Investigators think it is not suitable for the participants.
  • Any circumstance that the investigator considers may increase the risk to the subject or interfere with the results of the study.
  • Patients participate in other clinical studies.

结局指标

主要结局

Objective Response Rate (ORR) (PR+CR)

时间窗: 3 months

The proportion of patients with complete response(CR) or partial response(PR) as measured by International Working Group efficacy Criteria for myelodysplastic syndromes

次要结局

  • Overall survival(OS)(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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