Efficacy and Safety of Anti-CD30 CAR-T Therapy in Patients With Refractory/Relapsed Lymphocyte Malignancies：a Single-center, Open, Single-arm Clinical Study.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
The overall purpose of this study is to explore the safety and therapeutic effect of CD30-targeted chimeric antigen receptor T(CAR-T) cells in the treatment of Refractory/Relapsed lymphocyte malignancies.
详细描述
Chimeric antigen receptor (CAR)-modified T cells (CAR-T cells) have the capabilities to recognize tumor associated antigen and kill tumor cells specifically. CD30 is originally described as a marker of Hodgkin's and R-S cells in Hodgkin's lymphoma. CD30 antibody has been applied to treat lymphocyte derived malignancies. To explore the potency of CD30 in CAR-T therapy, this trial is designed and conducted to test the safety and efficacy of CD30-targeted CAR-T in Refractory/Relapsed lymphocyte malignancies.
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
- •Patient or his or her legal guardian voluntarily participates in and signs an informed consent form.
- •Male or female patients aged 18 to 70 years (including 18 and 70 years old).
- •Pathological and histological examination confirmed CD30+ lymphocyte malignancies, and patients currently have no effective treatment options, such as chemotherapy or recurrence after hematopoietic stem cell transplantation; or patients voluntarily choose Anti-CD30 CAR-T as rescue treatment.
- •CD30+ lymphocyte malignancies:
- •Adult T-cell leukemia/lymphoma
- •Anaplastic large cell lymphoma (ALCL);
- •Angioimmunoblastic T-cell Lymphoma (AITL);
- •NK/T-cell lymphoma;
- •Peripheral T-cell lymphoma (PTCL);
- •Hodgkin lymphoma;
- •There are still residual lesions after major treatment, and they are not suitable for HSCT (auto/allo-HSCT);
- •Recurrence occurs after CR1, and HSCT (auto/allo-HSCT) is not selected or suitable because of self-willingness;
- •After hematopoietic stem cell transplantation or cellular immunotherapy, the patient suffered relapse or did not remission.
- •Having a measurable or evaluable lesion.
- •Patient's main organs function well：
- •Liver function: ALT/AST < 3 times the upper limit of normal (ULN) and
- •total bilirubin≤34.2μmol/L
- •Renal function: Creatinine < 220μmol/L.
- •Pulmonary function: Indoor oxygen saturation≥95%.
- •Cardiac Function: Left ventricular ejection fraction (LVEF) ≥40%.
- •The patients did not receive any anticancer treatments such as chemotherapy, radiotherapy and immunotherapy (such as immunosuppressive drugs) within 4 weeks before admission, and the toxicity related to previous treatments had returned to < 1 level at admission (except for low toxicity such as alopecia).
- •The patient's peripheral superficial venous blood flow smoothly, which can meet the needs of intravenous drip.
- •Patient ECOG score≤2, Estimated survival time≥3 months.
排除标准
- •Women who are pregnant (urine/blood pregnancy test positive) or lactating.
- •Male or female with a conception plan in the past 1 years.
- •Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment.
- •Uncontrolled infectious disease within 4 weeks prior to enrollment.
- •Active hepatitis B/C virus.
- •HIV infected patients.
- •Suffering from a serious autoimmune disease or immunodeficiency disease.
- •The patient is allergic and is allergic to macromolecular biopharmaceuticals such as antibodies or cytokines.
- •The patient participated in other clinical trials within 6 weeks prior to enrollment.
- •Systemic use of hormones within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids).
- •Have a history of epilepsy or other central nervous system diseases.
- •Having drug abuse/addiction.
- •According to the researcher's judgment, the patient has other unsuitable grouping conditions.
研究组 & 干预措施
Anti-CD30 CAR T cells
Patients receive CD30 CAR-T cells transduced with a lentiviral vector on day 0 in the absence of disease progression or unacceptable toxicity. Autologous 3th generation anti-CD30 CAR T cells.
干预措施: Anti-CD30 CAR T cells (Genetic)
结局指标
主要结局
Number of participants with adverse events
时间窗: 3 years
Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0).
次要结局
- One-month remission rate(1 month)
- Quantity of anti-CD30 CAR copies in bone marrow cells and peripheral blood cells(3 years)
- Event-free survival(3 years)
- Overall survival(3 years)
- Relapse-free survival(3 years)
- Quantity of anti-CD30 CAR-T cells in bone marrow cells and peripheral blood cells(3 years)
研究者
MEI HENG
Principal Investigator
Wuhan Union Hospital, China