NCT07280494招募中1 期
An Open-label, Clinical Study of CD7-targeted CAR-T Cells for the Treatment of Measurable Residual Disease of T-lymphoblastic Leukaemia/Lymphoma Post Allogeneic Stem Cell Transplantation
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- +1m MRD negtaive rate
研究概览
简要总结
To observe the efficacy and safety of CD7-targeted chimeric antigen receptor T cells in the treatment of T-lymphoblastic leukaemia/lymphoma with postive measurable residual disease positive post allogeneic stem cell transplantation
详细描述
This study will explore the efficacy and safety of a natural selection-targeted CD7 CART cell therapy for measurable residual disease after allogeneic hematopoietic stem cell transplantation in T-ALL/LBL. The dose of targeted CD7 CART cells is 2E6 cells/kg, with a single infusion.
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 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) The subject or the legal guardian understands and voluntarily signs the informed consent form (ICF).
- •(2) Male or female, age ≥ 3 years at the time of signing the informed consent form.
- •(3) Expected survival period of no less than 12 weeks. (4) ECOG performance score of 0-2 at the time of signing the ICF. (5) Confirmed as relapsed/refractory T-cell leukemia or lymphoma at the time of signing the ICF, meeting the following criteria:
- •Bone marrow morphology examination at screening shows the proportion of primitive immature lymphocytes in the bone marrow < 5%, and positive for minimal residual disease of leukemia/lymphoma determined by flow cytometry.
- •Tumor cells in the bone marrow or peripheral blood are CD7 positive as detected by flow cytometry.
- •(6) Major organ functions must meet the following requirements:
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5× upper limit of normal (ULN).
- •Total bilirubin ≤ 2× ULN.
- •For adult subjects, the serum creatinine clearance rate ≥ 60 mL/min (Cockcroft-Gault formula) or serum creatinine ≤ 1.5× ULN; for children, the serum creatinine should be no more than 0.8 mg/dL for 2 to 6 years old, 1.0 mg/dL for 6 to 10 years old, 1.2 mg/dL for 10 to 13 years old, 1.5 mg/dL for 13 to 16 years old males, and 1.4 mg/dL for females over 13 years old; for males over 16 years old, it should be no more than 1.7 mg/dL.
- •If the above organ function abnormalities are caused by infiltration of the primary disease, the decision on whether to include the subject in the study is made by the investigator.
- •(7) Blood oxygen saturation > 92%. (8) Male subjects with reproductive capacity and female subjects of childbearing age must agree to use effective contraceptive measures from the time of signing the informed consent form until 2 years after the use of the study drug. Female subjects of childbearing age include premenopausal women and women within 2 years after menopause. The blood pregnancy test of female subjects of childbearing age at screening must be negative.
排除标准
- •Subjects with any of the following conditions will not be eligible for inclusion in this study.
- •A history of CNS diseases, including but not limited to epilepsy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, and neuropathy. A history of diseases without related neurological symptoms before screening, such as lacunar infarction, etc., will be excluded at the discretion of the investigator.
- •Any uncontrolled active infection within 4 weeks before signing the ICF or before apheresis.
- •Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) at screening and peripheral blood hepatitis B virus (HBV) DNA above the detection limit, positive hepatitis C virus (HCV) antibody and positive HCV RNA, positive human immunodeficiency virus (HIV) antibody, cytomegalovirus (CMV) DNA above the detection limit, Epstein-Barr virus (EBV) DNA above the detection limit, and both specific and non-specific antibodies for Treponema pallidum positive need to be excluded.
- •Clinically significant cardiovascular diseases, including any of the following:
- •Corrected QTc interval ≥ 480 ms (QTc interval calculated by the Fridericia formula);
- •New York Heart Association (NYHA) class II or higher heart failure;
- •Unstable angina or acute myocardial infarction within 6 months before signing the ICF;
- •Left ventricular ejection fraction (LVEF) < 50%;
- •Uncontrolled hypertension (judged by the investigator based on the individual condition of the subject);
- •Clinically significant or requiring antiarrhythmic treatment arrhythmias (such as sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes, and complete left bundle branch block, etc.).
- •Allergy to any component of the drugs to be used in this study.
- •Received any investigational drug treatment or other systemic anti-tumor treatment within 4 weeks before apheresis (or 5 half-lives of the drug, whichever is judged more appropriate by the investigator), except for bridging chemotherapy due to large tumor burden or rapid disease progression.
- •Received extensive radiotherapy within 4 weeks before signing the ICF, except for local radiotherapy for symptom relief of non-target lesions during the study period.
- •Received systemic corticosteroids (dose equivalent to or higher than 10 mg/day of prednisone) or other immunosuppressive drugs within 3 days before apheresis or during the study period, except for the following situations:
- •Intranasal, inhaled, topical steroids or local steroid injections (such as intra-articular injections);
- •Systemic corticosteroids at a dose not exceeding 10 mg/day of prednisone or its equivalent physiological dose;
- •Steroids as prophylactic treatment for allergic reactions (such as pre-treatment before computed tomography [CT]);
- •For the treatment of adverse reactions after reinfusion.
- •Received major surgery within 4 weeks before signing the ICF (routine biopsy surgeries excluded), or expected to undergo major surgery during the study period.
- •Had active tuberculosis infection within 1 year before signing the ICF (except for subjects with active tuberculosis infection more than 1 year ago and judged by the investigator to have no evidence of active tuberculosis at present).
- •Received live attenuated vaccines within 4 weeks before signing the ICF or planned to receive live attenuated vaccines during the screening period.
- •The investigator believes that the subject's complications or other conditions may affect compliance with the protocol or are not suitable for participation in this study.
- •Pregnant or lactating.
研究组 & 干预措施
anti CD7 CAR-T cells therapy
Experimental
eligible patients will be treated with CD7-targeted CAR-T cells
干预措施: CAR-T Therapy (Drug)
结局指标
主要结局
+1m MRD negtaive rate
时间窗: 28 days post CAR-T infusion
The MRD negative rate post CAR-T infusion
次要结局
- +2m MRD negative rate(at 2 months post CAR-T infusion)
- +3m MRD negative rate(at 3 months post CAR-T infusion)
- survival(at 1 year post CAR-T infusion)
- relapse(at 1 year post CAR-T infusion)
- GVHD(1 year post CAR-T infusion)
- hematological toxicity(3 months post CAR-T therapy)
研究者
Xiao-Jun Huang
Chief
Peking University People's Hospital
研究点 (1)
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