NCT06389305招募中不适用
Cytokine-induced Killer(CIK) Cell Therapy and Its Impact on Early Functional Exhaustion of Chimeric Antigen Receptor-T(CAR-T) Cells in Relapsed or Refractory Acute B-Lymphoblastic Leukemia: A Prospective Study
Beijing GoBroad Hospital1 个研究点 分布在 1 个国家目标入组 213 人开始时间: 2024年5月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 213
- 试验地点
- 1
- 主要终点
- Event-free survival(EFS) in CIK infusion group
研究概览
简要总结
This is a single-center, double-blind, randomized trial. Patients with relapsed or refractory acute B-lymphoblastic leukemia(r/r B-ALL) experiencing early functional exhaustion of CAR-T cells will be randomly allocated into three groups: the control cell group, the CIK treatment group, and the messenger RNA(mRNA)-CIK treatment group. The primary objective of the study is to evaluate the prognostic impact of CIK cell therapy on the early functional exhaustion of CAR-T cells in children and adolescent and young adult (AYA) with r/r B-ALL. The primary endpoint of the study is the event-free survival rate of these patient in the CIK cell therapy group.A total number of 213 subjects will be enrolled.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Year 至 39 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A patient must meet all of the following to be enrolled:
- •A confirmed diagnosis of refractory or relapsed B-ALL (criteria reference: NCCN, 2024.4), where all patients meet the National Comprehensive Cancer Network(NCCN) guidelines for the diagnosis of acute lymphoblastic leukemia (hematopathological examination of bone marrow aspirate and biopsy tissue showing ≥20% lymphoblasts in the bone marrow, confirmed by comprehensive flow cytometry (FCM) immunotyping, minimal residual disease analysis, and G-banded metaphase chromosome karyotype analysis). Molecular characteristics can be described through methods such as interphase fluorescence in situ hybridization (FISH) testing, reverse transcription polymerase chain reaction (RT-PCR) testing, and next-generation sequencing (NGS) for comprehensive detection of fusion genes and pathogenic mutations. Determination can also be made by the World Health Organization's subtypes of acute lymphoblastic leukemia, as well as cytogenetic and clinical risk groups.
- •Loss of CAR-T cell activity within 6 months after previous CAR-T therapy and no relapse.
- •Age between 1 and 39 years old.
- •No severe allergic constitution.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- •Life expectancy, as judged by the investigator, of at least 60 days.
- •Patients with self-awareness between 8 and 39 years of age voluntarily sign an informed consent, and the legal representative (guardians) of child patients under 18 years of age voluntarily signs an informed consent.
排除标准
- •A patient with at least one of the following conditions will be excluded:
- •Received bendamustine treatment within the past 9 months;
- •Intracranial hypertension or impaired consciousness in the brain;
- •Symptomatic heart failure or severe arrhythmia;
- •Symptoms of severe respiratory failure;
- •With other types of malignant tumors;
- •Disseminated intravascular coagulation;
- •Serum creatinine and/or blood urea nitrogen ≥ 1.5 times the normal value;
- •Suffering from sepsis or other uncontrollable infections;
- •Uncontrollable diabetes;
- •Severe mental disorders;
- •Significant lesions in the brain as detected by head magnetic resonance imaging;
- •Leukemic cells in the cerebrospinal fluid >20 cells/μL;
- •Peripheral blood leukemic cell proportion >30%;
- •Have undergone organ transplantation;
- •Female patients (those with childbearing potential) are pregnant or lactating;
- •Active or uncontrollable infectious diseases, such as hepatitis (HBV, HCV), HIV, or syphilis.
研究组 & 干预措施
peripheral blood lymphocytes
Placebo Comparator
干预措施: peripheral blood lymphocytes (Drug)
CIK cells
Experimental
干预措施: CIK cell (Drug)
结局指标
主要结局
Event-free survival(EFS) in CIK infusion group
时间窗: 2-year EFS rate
EFS is defined as the time from CIK-cell infusion to the earliest relapse, death from any cause, or treatment failure
次要结局
- Progression-free survival(PFS) in CIK infusion group(2-year PFS rate)
- Duration of response(DOR) in CIK infusion group(from enrollment to the end of treatment at 15 years)
- Overall survival(OS) in CIK infusion group(from enrollment to the end of treatment at 15 years)
- EFS in mRNA-CIK infusion group(2-year EFS rate)
研究者
Jing Pan
Director of Dept of Hemato-Oncology and Immunotherapy
Beijing GoBroad Hospital
研究点 (1)
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