NCT04840875已完成1 期
Phase I Clinical Trial of Autologous CD7-CAR T Cells in the Treatment of High-risk Acute T-cell Leukemia / Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- DLT rate
研究概览
简要总结
This is a phase 1 clinical trial of autologous CD7-CAR T cells in the treatment of high-risk acute T-cell leukemia / lymphoma. Twenty subjects will be enrolled. Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: about 3 days before cells transfusion, the patients who planned to reinfuse CAR T cells were treated with fluorodarabine 30 mg/m2( body surface area) and cyclophosphamide 250 mg/m2( body surface area) for 3 days. Then this study will be using a 3+3 dose escalation approach from dose 1 (DL-1): 5×105 (±20%) to dose 2 (dl-2): 1×106 (±20%). Below the lowest dose was reinfused at the PI's discretion.
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
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Diagnosed as a high-risk acute T-cell leukemia / lymphoma patient with complete remission within 3 months and persistent positive of minimal residual disease, expressing tumor surface antigen CD7
- •Refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma patients with no blasts in peripheral blood by flow cytometry and suspending anti-neoplastic treatment for more than 2 weeks
- •Male or female, aged 0-70 years
- •No serious allergic constitution
- •Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) score 0 to 2
- •Have life expectancy of at least 60 days based on investigator's judgement
- •CD7 positive in bone marrow or peripheral blood or immunohistochemistry
- •Candidates aged 8-70 years need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form. And Pediatric patients under 8 years old could be recruited after signing an informed consent form by a legal surrogate (Guardian)
- •Minimal residual disease was positive after chemotherapy and there were contraindications of allogeneic hematopoietic stem cell transplantation.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Intracranial hypertension or disorder of consciousness
- •Symptomatic heart failure or severe arrhythmia
- •Symptoms of severe respiratory failure
- •Complicated with other types of malignant tumors
- •Diffuse intravascular coagulation
- •Serum creatinine and / or blood urea nitrogen ≥ 1.5 times of the normal value
- •Suffering from septicemia or other uncontrollable infections
- •Patients with uncontrollable diabetes
- •Severe mental disorders
- •Obvious and active intracranial lesions were detected by cranial magnetic resonance imaging (MRI)
- •Have received organ transplantation (excluding hematopoietic stem cell transplantation);
- •Reproductive-aged female patients with positive blood HCG test
- •Screened to be positive of infection of hepatitis (including hepatitis B and C), AIDS or syphilis
研究组 & 干预措施
chimeric antigen receptor T cell treatment
Experimental
干预措施: chimeric antigen receptor T cell treatment (Biological)
结局指标
主要结局
DLT rate
时间窗: 21 days
The DLT rate to the CAR-T treatment
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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