A Prospective, Single-Arm, Single-Center Study of Autologous Hematopoietic Stem Cell Infusion for Prolonged Cytopenia After CAR-T Cell Therapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in Neutrophil Counts After Autologous Stem Cell Infusion
研究概览
简要总结
This is a prospective, single-arm, single-center clinical study designed to evaluate the safety of autologous hematopoietic stem cell infusion for the treatment of prolonged cytopenia following CAR-T cell therapy. Approximately 20 patients will be enrolled.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and willingness to sign a written informed consent form (ICF).
- •Age ≥ 18 years.
- •Diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) criteria.
- •Prior treatment with CAR-T cell therapy and currently in remission or, in the opinion of the investigator, with refractory/progressive disease not requiring salvage therapy.
- •Presence of grade 3-4 cytopenia (absolute neutrophil count < 1.0 × 10⁹/L, or platelet count < 50 × 10⁹/L, or hemoglobin < 80 g/L) either persisting or newly developed between day 30 and day 90 after CAR-T cell infusion; or deemed suitable for inclusion by the investigator based on clinical judgment.
- •Availability of ≥ 1 × 10⁶/kg autologous hematopoietic stem cells in reserve.
排除标准
- •Known intolerance, hypersensitivity, or contraindication to autologous hematopoietic stem cell infusion.
- •Active hepatitis B or hepatitis C virus infection.
- •Known HIV infection.
- •Life expectancy <6 months.
- •Woman who are pregnant or breastfeeding.
- •Evidence of uncontrolled dysfunction of heart, lung, brain, and other important organs.
- •Any other conditions that are not eligible for the trial in the judgement of the principal investigator.
研究组 & 干预措施
Autologous hematopoietic stem cell infusion
干预措施: Autologous hematopoietic stem cell infusion (Biological)
结局指标
主要结局
Changes in Neutrophil Counts After Autologous Stem Cell Infusion
时间窗: up to 6 months after infusion
Evaluate changes in neutrophil counts following autologous hematopoietic stem cell infusion.
Changes in Platelet Counts After Autologous Stem Cell Infusion
时间窗: up to 6 months after infusion
Evaluate changes in platelet counts following autologous hematopoietic stem cell infusion.
Incidence and Severity of Adverse Events Following Autologous Stem Cell Infusion
时间窗: up to 6 months after infusion
Assess safety by monitoring infusion-related adverse events, graded according to CTCAE v5.0.
Changes in Hemoglobin Levels After Autologous Stem Cell Infusion
时间窗: up to 6 months after infusion
Evaluate changes in hemoglobin levels following autologous hematopoietic stem cell infusion.
次要结局
- Incidence of Infections After Autologous Stem Cell Infusion(up to 6 months after infusion)