A Randomized Controlled, Open, Single-center Clinical Study Evaluating the Efficacy and Safety of Umbilical Cord Blood Mononuclear Cells in Patients with Refractory Immune Effector Cell-related Hemocytopenia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The recovery time of neutrophils
研究概览
简要总结
The purpose of this study was to evaluate the safety and efficacy of umbilical cord blood mononuclear cell in the treatment of refractory immune effector cell-related hemocytopenia by observing the efficacy related factors and adverse reactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old (including boundary values), gender is not limited
- •ECOG score 0-2 points
- •Expected survival ≥6 months
- •Patients who have received immune effector cell therapy (marketed CAR-T cell therapy or dual antibody therapy) (no target), have grade 3-4 hemocytopenia after treatment, and do not recover to grade 2 within 3 weeks after conventional treatment. Defined as follows:
- •The neutrophils again decreased to grade ≥3 within 1 week after G-CSF discontinuation, or 2) Unable to detach from red blood cell or platelet transfusion (infusion time less than one week requires re-infusion) (5) Understand the research protocol and sign the informed consent voluntarily
排除标准
- •Patients who intend to undergo autologous hematopoietic stem cell transfusion or have undergone autologous hematopoietic stem cell transfusion
- •Significant lack of compliance to complete the study plan (such as suffering from uncontrolled mental illness, etc.)
- •Allergy or known allergy to any drug active ingredients, excipients, and blood products or preparations included in this study
- •Pregnancy, breastfeeding, planning pregnancy, or unwillingness to use effective contraception as required by research
- •There are other conditions that researchers believe are not suitable for inclusion
研究组 & 干预措施
Conventional hematopoietic recovery therapy
Conventional hematopoietic recovery therapy including but not limited to G-CSF, TPO, TPO receptor agonists, transfusions of red blood cells, platelets, etc.
干预措施: Conventional hematopoietic recovery therapy (Combination Product)
Conventional hematopoietic recovery therapy+Umbilical cord blood mononuclear cells
Umbilical cord blood mononuclear cells are obtained from umbilical cord blood by density gradient centrifugation
干预措施: Umbilical cord blood mononuclear cells (Biological)
Conventional hematopoietic recovery therapy+Umbilical cord blood mononuclear cells
Umbilical cord blood mononuclear cells are obtained from umbilical cord blood by density gradient centrifugation
干预措施: Conventional hematopoietic recovery therapy (Combination Product)
结局指标
主要结局
The recovery time of neutrophils
时间窗: 1 year
On the first day after discontinuing G-CSF, the neutrophil count remained above 1.0 × 10\^9/L for 7 consecutive days
The recovery time of platelet
时间窗: 1 year
Starting from the second day of the most recent platelet transfusion, the first day of platelet count\>50 × 10\^9/L lasting for 7 days
Safety of infusion
时间窗: 1 year
Acute allergies or infections related to umbilical cord blood mononuclear cell infusion, as well as shock and other infusion related reactions symptoms including but not limited to chills, fever, CRP, PCT, etc
次要结局
- Recovery of hemoglobin levels after infusion(1 year)
- Immune function reconstruction indicators at 1, 3, 6, and 12 months after transfusion(1, 3, 6, and 12 months)
- Overall survival rate(2 and 5 year)
研究者
Kai Hu
Principal Investigator
Beijing GoBroad Hospital