NCT05059912Unknown2 期
Humanized CD7 CAR T-cell Therapy for R/R CD7+ T Cell Lymphoma
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年8月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
This is a prospective, open-label, multiple center and single arm phase 2 study to evaluate the efficacy and safety of T cells expressing humanized CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive T cell lymphoma.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •R/R T-NHL with measurable (≧1.5cm) lesions confirmed by pathological immunohistochemistry or flow cytometry
- •The expressions of both CD4 and CD8 are negative in patients with bone marrow involved
- •The Eastern Cooperative Oncoloy Group (ECOG) physical condition score ≤ 2 points
- •The main organ functions need to meet the following conditions:
- •A.Left ventricular ejection fraction ≥50% B.Creatinine ≤132umol/l or creatinine clearance ≥60 ml/min C.ALT and AST≤2.5 upper limitation of normal D.T-BIL≤2.0mg/dl E.SpO2 > 90%
- •Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion
- •Expected survival exceeds 3 months
- •Written informed consent could be acquired
排除标准
- •Immunosuppressant medications or steroids were used within 2 weeks before cell collection, or need to use steroids or immunosuppressant medications more than two years
- •Patients with uncontrolled active infection
- •Active hepatitis B or hepatitis C infection
- •Patients with HIV infection
- •Severe acute or chronic graft-versus-host disease (GVHD)
- •Participated in any other drug research clinical trials within 30 days before enrollment
- •Prior CAR-T cells therapy within 3 months before enrollment
- •Prior allogeneic hematopoietic stem cell transplantation within 6 months before enrollment
- •Uncontrolled other tumor
- •Women in pregnancy, lactation or planning to become pregnant
- •The researcher considers inappropriate to participate in this research
结局指标
主要结局
Overall response rate (ORR)
时间窗: 1 year
Number of patients who achieved response (complete response and partial response ) after treatment of CD7 CAR-T cell. Response will be assessed using the Lugano criteria.
Number of Adverse Events
时间窗: 1 year
Adverse events are evaluated with CTCAE V5.0
次要结局
- Complete relapse rate(CR)(1 year)
- Duration of overall response (DOR)(1 year)
- Progression-free survival(PFS)(1 year)
- Overall survival(OS)(1 year)
研究者
研究点 (1)
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