NCT04828174暂停1 期
The Safety and Clinical Efficacy of Human TRBC1 CAR-T Cell Therapy for Patients With Relapsed/Refractory TRBC1 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 9 人开始时间: 2021年3月31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
- 暂停
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
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 TRBC1 in patients with relapsed or refractory TRBC1 positive T-cell hematological maliganacies
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1)18 to 70 Years Old, Male and female; (2) Expected survival > 12 weeks; (3) ECOG score 0-2; (4) Confirmed diagnosis of acute T cell leukemia and screened for TRBC1 positive, including following conditions:
- •Patients who do not get a CR with ≥2 prior lines of therapy
- •Those who achieves CR, but have a early relapse(<12months),or a late relapse (>=12months) failing to acheive a CR after 1 line salvage chemotherapy
- •For any Patiens failed ASCT/allo-SCT (5) Relapsed and refractory patients with diagnosis of T cell lymphoma have had≥2 prior lines of therapy,including:
- •a. Peripheral T cell lymphoma NOS, or b. Angioimmunoblastic T cell lymphoma, or c. Anaplastic large cell lymphoma (6) Confirmed T lymphoblatic lymphoma
- •Patients who do not get a CR with ≥2 prior lines of therapy
- •Relapsed patients failing to acheive a CR after 1 line salvage chemotherapy
- •For any Patiens failed ASCT/allo-SCT (7) The venous access required for collection can be established and mononuclear cell collection can be determined by the investigators; (8) Liver, kidney and cardiopulmonary functions meet the following requirements:
- •a. Ccr≥60mL/min(Cockcroft Gault) b. Left ventricular ejection fraction >50%; c. Baseline oxygen saturation>92%; d. Total bilirubin ≤ 1.5×ULN; e. ALT and AST ≤ 3×ULN; (9) Able to understand and sign the In
排除标准
- •Malignant tumors other than acute lymphoblastic leukemia 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;patients with positive HBsAg or HBcAb and peripheral blood HBV DNA titer detection ≥ 1 × 10^2 copy number / L; HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; CMV DNA 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;
- •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-TRBC1 CAR-T cell
Experimental
Administration with anti-TRBC1 CAR-T cells in the relapsed/refractory T cell hematological malignancy patients.
干预措施: anti-TRBC1 CAR-T cell therapy (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: 28 days post infusion
Safety measured by occurence of study related adverse effects defined by NCI CTCAE5.0
次要结局
- Progression Free Survival (PFS) after infusion(2 years after infusion)
- Total response rate (ORR) after administration(3 months post infusion)
- CAR-T cell expansion and persistence(2 years post infusion)
- Overall Survival (OS)after administration(2 years post infusion)
- Duration of remission (DOR) 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)
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