NCT04959903招募中1 期
A Phase I/II Study Evaluating the Safety and the Efficacy of SMART101 Injection to Accelerate Immune Reconstitution After T Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation in Pediatric and Adult Patients With Hematological Malignancies
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- CD4+ T cell count
研究概览
简要总结
The purpose of this study is to evaluate the safety and the efficacy of SMART101 (Human T Lymphoid Progenitor (HTLP)) injection to accelerate immune reconstitution after T cell depleted allogeneic hematopoietic stem cell transplantation (HSCT) in adult and pediatric patients with hematological malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Group A (adults):
- •Adult patients affected by:
- •Acute leukemia (AML, ALL) defined as:
- •Acute Myeloid Leukemia (AML):
- •High risk AML in CR1; any adverse genetic abnormality, secondary or therapy related AML excluding good risk genetic abnormalities
- •Chemo-refractory relapse (MRD+)
- •Acute Lymphoblastic Leukemia (ALL):
- •Chemo-refractory relapse (MRD+)
- •High risk ALL in CR1; Philadelphia (like) or any poor risk feature
- •Acute leukemia of ambiguous lineage:
- •≥ CR1 with a minimal residual disease (MRD) <5% (flow cytometry, molecular and/or cytogenetics accepted)
- •Myelodysplastic Syndrome (MDS) with least one of the following:
- •Revised International Prognostic Scoring System risk score of intermediate or higher at the time of transplant evaluation.
- •Life-threatening cytopenia.
- •Karyotype or genomic changes that indicate high risk for progression to acute myelogenous leukemia, including abnormalities of chromosome 7 or 3, mutations of TP53, or complex or monosomal karyotype.
- •Therapy related disease or disease evolving from other malignant processes.
- •Patient eligible for a T-depleted allogeneic HSCT
- •Age ≥ 18y and clinical condition compatible with allogeneic stem cell transplantation
- •Karnofsky index ≥ 70% prior to conditioning regimen
- •Patients with normal organ function prior to conditioning regimen
- •Group B (pediatrics):
- •Pediatric patients affected by acute leukemia defined as:
- •Acute Myeloid Leukemia (AML):
- •High risk AML in CR1; any adverse genetic abnormality, secondary or therapy related AML excluding good risk genetic abnormalities,
- •Chemo-refractory relapse (MRD+)
- •Acute Lymphoblastic Leukemia (ALL):
- •Chemo-refractory relapse (MRD+)
- •High risk ALL in CR1; Philadelphia (like) or any poor risk feature
- •Acute leukemia of ambiguous lineage:
- •≥ CR1 with a minimal residual disease (MRD) <5% (flow cytometry, molecular and/or cytogenetics accepted)
- •Patient eligible for a T-depleted allogeneic HSCT
- •Age < 18y at the time of inclusion
- •Absence of a matched sibling donor (MSD)
- •Lansky ≥ 70% / Karnofsky performance status ≥ 70% prior to conditioning regimen
- •Patients with normal organ function prior to conditioning regimen
排除标准
- •Groups A and B:
- •Use of an HLA matched Cord Blood (8/8 allele matched) or haploidentical donor
- •Prior therapy with allogeneic stem cell transplantation
- •Treatment with another cellular therapy within one month before inclusion
结局指标
主要结局
CD4+ T cell count
时间窗: 100 days post-HSCT
to evaluate the efficacy of the study drug
Occurrence of adverse events related to SMART101
时间窗: 100 days post-HSCT
Number of adverse events and serious adverse events related to SMART101 tabulated for each dose and by age group to evaluate the safety profile of the study drug
Cumulative incidence of grade III-IV GvHD
时间窗: 100 days post-HSCT
to evaluate the safety profile of the study drug
次要结局
- Cumulative incidence of infections(Day 90, and Months 6, 12 and 24 post-HSCT)
- T cell immune reconstitution(up to Month 12 post-HSCT)
- Non-relapse mortality (NRM)(Day 90, and Months 6, 12 and 24 post-HSCT)
研究者
研究点 (1)
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