NCT05290155已完成1 期
The Safety and Clinical Efficacy of Human CD7 CAR-T Cell Therapy for Patients With Relapsed/Refractory CD7 Positive T Cell Hematological Maliganacies
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2022年5月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of CAR T cell treatment targeting CD7 in patients with relapsed or refractory CD7 positive T-cell hematological maliganacies
详细描述
This study is single-armed，open lable，dose escalation clinical trial.The main purpose is to evaluate the safety and efficacy of anti-CD7 CAR-T cells in relapsed/refractory patients with CD7 positive T cell malignancies,including T lymphoblastic lymphoma/leukemia ,T-cell non-Hodgkin lymphoma(peripheral T cell lymphoma,NOS,angioimmunoblastic T cell lymphoma and anaplastic large cell lymphoma).There will be three CAR T cell dose groups:0.25*10^6 cells per kilogram of body weight;0.5*10^6 cells per kilogram of body weight，1 *10^6 ells per kilogram of body weight.
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
- 14 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Malignant tumors other than T cell malignancies within 5 years prior to screening, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ after radical resection;
- •Uncontrolled infection including bacteral or virus or fugal disease;patients with positive HBsAg or HBcAb and positive peripheral blood HBV DNA titer detection ;HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; syphilis positive;
- •Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening),myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia,liver, kidney, or metabolic disease;
- •Any uncontrolled disease may affect entry
- •Current or history of CNS involvement by malignancy.Known history or presence of clinically relevant central nervous system (CNS) pathology.Patients with a known history or prior diagnosis other immunologic or inflammatory disease affecting the CNS (such as epilepsy)
- •Patients who are receiving systemic steroid treatment and requiring long-term systemic steroid treatment during the treatment as determined by the investigator before screening (except inhalation or topical use); And subjects treated with systemic steroids (except inhalation or topical use) within 72h prior to cell transfusion;
- •Subjects treated with anti-PD1 or anti-PDL1 therapies within 3months before enrollment
- •Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pr egnancy within 1 year after cell transfusion;
- •Active or uncontrollable infection requiring systemic therapy Received CAR-T treatment or other gene therapies before enrollment;
- •Kown be allergic to anti-TRBC1 CAR-T cells or drugs(Fludarabine or Cyclophophamide)
- •The investigators consider other conditions unsuitable for enrollment.
- •Patients who may not be able to sign the Informed Consent due to disease,or who do not understand or unwillingness or inability to comply with research requirements
研究组 & 干预措施
Anti-CD7 CAR T cells
Experimental
Administration with anti-CD7 CAR-T cells in the relapsed/refractory T cell hematological malignancy patients
干预措施: anti-CD7 CAR-T cells (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: 28 days post infusion
The occurence of study related adverse effects defined by NCI CTCAE5.0
次要结局
- Number of CD7+ lymphocytes of peripheral blood(2 years post infusion)
- Total response rate (ORR) after administration(3 months post infusion)
- CAR-T cell persistence(2 years post infusion)
- CAR-T cell expansion(2 years post infusion)
- Duration of remission (DOR) after administration(2 years post infusion)
- Overall survival(OS) after administration(2 years post infusion)
- Progression Free Survival (PFS) after administration(2 years post infusion)
研究者
Xianmin Song, MD
principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
研究点 (1)
Loading locations...
相似试验
Unknown
1 期
Anti-CD7 CAR-Engineered T Cells for T Lymphoid Malignancies MalignanciesT-Cell Lymphocytic LeukemiaT-Cell Chronic Lymphocytic LeukemiaT Cell Non-Hodgkin LymphomaNCT04823091Wuhan Union Hospital, China24
进行中（未招募）
不适用
Clinical Study of SenL-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic LymphomaSenL-T7 CAR T Cells for CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic LymphomaNCT04916860Hebei Senlang Biotechnology Inc., Ltd.100
招募中
1 期
Clinical Study on the Safety and Efficacy of CD7 CAR-T Cell Sequential Allo-HSCT and Kidney Transplantation in the Treatment of SIODSchimke Immuno-osseous DysplasiaNCT06769191Zhejiang University20
招募中
早期 1 期
Clinical Study of Targeting CD7 CAR-T Cells in the Treatment of Autoimmune DiseasesUlcerative ColitisAutoimmune DiseasesCrohn DiseaseDermatomyositisStill DiseaseNCT05239702Zhejiang University75
尚未招募
1 期
Safety and Efficacy of CD207 Targeted CAR-T Cell Therapy in Patients With R/R Langerhans Cell HistiocytosisLangerhans Cell HistiocytosisNCT05477446Beijing Friendship Hospital12