NCT05210907招募中1 期
A Phase Ib, Clinical Trial of Hospital-manufactured CD19 Chimeric Antigen Receptor T Cells (SNUH-CD19-CAR-T) in Children and Adolescents With Relapsed or Refractory CD19 Positive Acute Lymphoblastic Leukemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Incidence of adverse events and its severity
研究概览
简要总结
Chimeric antigen receptor T cells (CAR-T cells) have been developed to treat relapsed and refractory hematological malignancies with promising outcome in patients with very poor prognosis. The purpose of this clinical study is to produce the CD19[cluster of differentiation antigen 19] CAR-T (SNUH-CD19-CAR-T) at the investigational site and to evaluate safety and efficacy of SNUH-CD19-CAR-T in children and adolescent with relapsed/refractory B-cell acute lymphoblastic leukemia.
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
- 0 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsed or refractory CD19 Positive Acute Lymphoblastic Leukemia. All subjects must be younger than 26 years old at the time of obtaining informed consent
- •a. 2nd or greater BM[bone marrow] relapse OR b. Any BM relapse after allogeneic SCT[stem cell transplant] and must be ≥ 6 months from SCT at the time of SNUH_CD19_CAR-T infusion OR c .Refractory as defined by not achieving a CR after 2 cycles of a standard chemotherapy regimen or chemorefractory as defined by not achieving a CR after 1 cycle of standard chemotherapy for relapsed leukemia OR d. Ineligible for allogeneic SCT because of:
- •Severe comorbid disease
- •Other contraindications to allogeneic SCT conditioning regimen
- •Lack of suitable donor
- •Documentation of CD19 tumor expression in bone marrow or peripheral blood by flow cytometry.
- •Karnofsky (age ≥ 16 years) or Lansky (age < 16 years) performance status ≥ 50 at screening
排除标准
- •Evidence of uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV) based on assessment done by treating physicians.
- •Known human immunodeficiency virus (HIV) infection.
- •Presence of clinically active uncontrolled infection based on assessment done by treating physicians. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of progression are present. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
- •Pregnant or nursing (lactating) women.
结局指标
主要结局
Incidence of adverse events and its severity
时间窗: 12 months post SNUH-CD19-CAR-T infusion
次要结局
- Patients with CR[complete remission] after Hospital-manufactured CAR-T infusion(1 month post SNUH-CD19-CAR-T infusion)
- Overall survival and event-free survival(12 months post SNUH-CD19-CAR-T infusion)
研究者
研究点 (2)
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