NCT07338357撤回1 期
A Single-Center Clinical Study Evaluating the Safety and Preliminary Efficacy of CLL-1 CAR-T in the Treatment of Children With Relapsed/Refractory Acute Myeloid Leukemia
First Affiliated Hospital of Guangxi Medical University0 个研究点目标入组 10 人开始时间: 2026年1月5日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 10
- 主要终点
- Incidence of Treatment-Related Adverse Events
研究概览
简要总结
A study to evaluate the safety and preliminary efficacy of CLL-1-targeted CAR-T cell therapy in children aged 3 to 18 years with relapsed or refractory acute myeloid leukemia (r/r AML).
详细描述
It's a single-center, single-arm, investigator-initiated clinical study. After thorough consideration and signing of the informed consent form by the subject and/or their legal guardian(s), subjects meeting the eligibility criteria during the screening period will provide blood samples for CAR-T manufacturing. Following lymphodepleting chemotherapy, CAR-T cell infusion will be administered on D0.
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
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign the ICF and are expected to complete the study's follow-up examinations and procedures.
- •Aged 3 to 18 years (inclusive), and body weight ≥10 kg.
- •Diagnosis of AML according to the 2016 WHO classification, meeting the diagnostic criteria for relapse and refractoriness as per the "Chinese Guidelines for Diagnosis and Treatment of Relapsed/Refractory Acute Myeloid Leukemia (2017 Edition)", and currently having no clinically relevant treatment options or suitable registered clinical trials available.
- •Confirmation of CLL-1 expression ≥50% on AML blasts by flow cytometry.
- •Recovery from toxicities of prior therapies.
- •Karnofsky score (for age ≥16 years) ≥70 or Lansky score (for age <16 years) ≥50 at screening, and an expected survival >3 months.
- •Suitable function of the liver, kidneys, hematological system, lungs and heart is required.
- •Females subjects of childbearing potential must have a negative blood pregnancy test at screening and agree to use effective contraception during the study and within 1 year after the last dose of study drug.
- •Male subjects with reproductive potential must agree to use barrier contraception or practice complete abstinence until 1 year after the last study treatment.
- •Eligible blood cell specimen can be provided.
排除标准
- •Diagnosis of APL.
- •History of other malignancies within 3 years prior to screening, except for adequately treated carcinoma in situ of the cervix, papillary thyroid carcinoma, basal cell or squamous cell skin cancer, localized prostate cancer treated with radical surgery, and ductal carcinoma in situ treated with radical surgery.
- •Evidence of CNS involvement or cranial nerve pathology.
- •Subjects with active infections such as hepatitis B, hepatitis C, etc., are to be excluded.
- •Subjects with a history of severe allergies or known allergy to any drug component included in this study are to be excluded.
- •Subjects with severe cardiac diseases, refractory hypertension, active neurological autoimmune or inflammatory diseases, clinically significant active cerebrovascular disease, oncologic emergencies requiring urgent intervention, acute or chronic GVHD, or any uncontrolled infections requiring antibiotic therapy, etc., are unsuitable for enrollment.
- •Previous organ transplant or planned organ transplant (except for hematopoietic stem cell transplantation).
- •Received allo-HSCT within 6 weeks prior to screening.
- •Subjects who have recently undergone major surgery or plan to undergo major surgery, excluding diagnostic procedures and biopsies.
- •Subjects with severe mental disorders, alcoholism, or drug abuse.
- •Subjects who, in the judgment of the investigator, have other conditions that make them unsuitable for enrollment.
研究组 & 干预措施
CAR-T
Experimental
CAR-T therapy
干预措施: CAR-T (Biological)
结局指标
主要结局
Incidence of Treatment-Related Adverse Events
时间窗: Up to 2 years.
Proportion of subjects experiencing all kinds of treatment-related AEs.
次要结局
- Overall Survival(Up to 2 years.)
- Overall Response Rate(Up to 2 years.)
- Duration of Response(Up to 2 years.)
- Relapse-Free Survival(Up to 2 years.)
- Event-Free Survival(Up to 2 years.)
- Overall Survival(Up to 2 years.)
- Proportion of CLL-1-Positive Tumor Cells(Up to 2 years.)
研究者
Yunyan He
PhD
First Affiliated Hospital of Guangxi Medical University
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