NCT06225050招募中不适用
A Single-center Pilot Study Using TCRα/β and CD45RA Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Cell Transplantation in Adults(HAPLO2022)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Incidence of severe acute GVHD (aGVHD) till Day 100
研究概览
简要总结
This is a single-center, open-label, single-arm, pilot clinical study using TCRα/β and CD45RA depleted stem cell grafts from haploidentical donors for hematopoietic cell transplantation in 12 to 18 adult patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients, between 18 years to 75 years of age, with high-risk hematological malignancy requiring an allogeneic hematopoietic stem cell transplantation (AlloHCT), but do not have an HLA-matched donor available
排除标准
- •<3 months after preceding autologous transplantation or prior AlloHCT
- •History of neurological impairment (active seizures, severe peripheral neuropathy, signs of leukoencephalopathy, active CNS infection)
- •Active fungal infections with radiological and clinical progression
- •Liver function abnormalities with bilirubin >2 mg/dL and elevation of transaminases higher than 400 U/L
- •Chronic active viral hepatitis
- •Cardiac dysfunction: adult patients ejection fraction <50% on echocardiography
- •Patients with uncontrolled, >grade II hypertension (per Common Toxicity Criteria, CTC)
- •Creatinine clearance <60 mL/min/1.73m2
- •Respiratory failure necessitating supplemental oxygen
- •HIV infection
- •Positive anti-donor HLA antibody
- •Treatment with checkpoint inhibitors in the period between 3 months prior to and 3 months after transplantation
- •Female patients who are pregnant or breast feeding, or adults of reproductive potential not willing to use an effective method of birth control during study treatment and for at least 12 months thereafter. Note: Women of childbearing potential must have a negative serum pregnancy test at study entry
- •Concurrent severe or uncontrolled medical disease (e.g., uncontrolled diabetes, myocardial infarction within 6 months prior to the study) which by assessment of the treating physician could compromise participation in the study
- •Patients with a history of psychiatric illness or a condition which could interfere with their ability to understand the requirements of the study (this includes alcoholism/drug addiction).
- •Patients unwilling or unable to comply with the protocol or unable to give informed consent
- •Treatment with any investigational product within 4 weeks prior to study treatment
研究组 & 干预措施
HSC Recipient
Experimental
PBSC grafts from haploidentical donors depleted of TCRaβ+ cells and CD45RA+ cells using CliniMACS Prodigy® will be infused into patients intravenously (IV)
干预措施: CliniMACS Prodigy® LP-TCRα/β-19-45RA (Trial Version) (Device)
结局指标
主要结局
Incidence of severe acute GVHD (aGVHD) till Day 100
时间窗: 100 days after haploidentical hematopoietic cell transplantation
Participants will be evaluated for the occurrence of aGVHD, grades III-IV in the first 100 days after transplantation and the time to occurrence of aGVHD, grades III-IV will be recorded. Severity of acute GVHD will be graded according to the CONSENSUS CRITERIA FOR GRADING OF ACUTE GVHD which has four Grades from Grade I to Grade IV. The higher the Score, the Worse the outcome.
次要结局
- Platelet Engraftment(Day 0)
- Chronic GVHD(1 Year)
- Performance of the CliniMACS Prodigy® LP-TCRα/β-19-45RA(Trial Version)(Until Last Patient Last Visit(24 Months))
- Incidence of acute GVHD (aGVHD) till six months post-transplantation(6 Months)
- Non-relapse mortality (NRM)(Until Last patient last Visit(24 Months))
- Graft failure(30 Days)
- Relapse rate(12 Months)
- Hospitalization length/re-admission(Assessed at Day 30, Day 100 and at 12 Months post transplantation)
- Neutrophil Engraftment(Day 7)
- Infusion toxicity(15 minutes, 30 minutes, 2 hours, and 4 hours post infusion)
- Overall survival (OS)(Day 100 and through study completion, an average of 1 year post transplantation)
- Disease-free survival (DFS)(Day 100 and through study completion, an average of 1 year post transplantation)
- GVHD/relapse-free survival (GRFS)(GRFS will be assessed at Month 12 post transplantation)
- Immunosuppression-free survival (ISFS)(Assessed at 1 year with a starting point at Day 45 post-transplantation)
研究者
研究点 (1)
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