NCT04007978Unknown1 期
Efficacy and Safety of Anti-CD22 CAR-T Therapy in Patients With Relapsed/Refractory B-cell Malignancies: a Single-center, Open-label, Single-arm Clinical Study
Wuhan Union Hospital, China1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年8月5日最近更新:
适应症
干预措施
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
This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of anti-CD22 CAR-T cells in patients with relapsed or refractory B-cell 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. CAR-T therapy showed great effect on patients with relapsed or refractory B-cell malignancies. CAR consists of single chain variable fragment (scFv) and activation domain of T cell. In preclinical study, the researchers constructed a third generation CAR containing CD137 and CD28 costimulatory domains.
This study aims to evaluate the safety and effectiveness of anti-CD22 CAR-T cells in patients with relapsed or refractory B-cell 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
- 14 Years 至 70 Years（Child, 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 14 to 70 years (including 14 and 70 years old).
- •Pathological and histological examination confirmed CD22+ B-cell malignancies, and patients met the following criteria for refractory or relapsed B-cell malignancies.
- •A.Refractory/relapsed B-cell lymphoblastic leukemia (Meeting one of the following)
- •i. Recurrence within 6 months after first remission.
- •ii. Primary refractory disease which cannnot achieve complete remission (CR) after 2 cycles of standardized chemotherapy regimen.
- •iii. Failure to achieve CR or relapse after one line or multiple lines of salvage chemotherapy.
- •iv. Not suitable for hematopoietic stem cell transplantation (HSCT), or abandon HSCT due to various restrictions, or relapse after HSCT.
- •B.Refractory/relapsed B-cell lymphoma (Meeting 1 of the first 4 items plus item 5)
- •i. Tumor shrinkage less than 50% or disease progression after 4 cycles of standard chemotherapy.
- •ii. Achieved CR after standard chemotherapy, but relapsed within 6 months.
- •iii. 2 or more relapses after CR.
- •iv. Not suitable for HSCT, or abandon HSCT due to various restrictions, or relapse after HSCT.
- •v. Subjects must have received adequate treatment in the past, including anti-CD20 monoclonal antibody and combination chemotherapy with anthracyclines.
- •B-cell malignancies include the following three types
- •A. B-cell acute lymphoblastic leukemia (B-ALL)
- •B. Indolent B-cell lymphoma (CLL, FL, MZL, LPL, HCL)
- •C. Invasive B-cell lymphoma (DLBCL, BL, MCL)
- •Having a measurable or evaluable lesion
- •A. Patients with lymphoma require a single lesion≥15mm or 2 or more lesions≥10mm.
- •B. Patients with leukemia require persistent positive or positive relapse of bone marrow MRD.
- •Patient's main organs functioning well
- •A. Liver function: ALT/AST < 3 times the upper limit of normal (ULN) and total bilirubin≤34.2μmol/L
- •B. Renal function: Creatinine < 220μmol/L.
- •C. Pulmonary function: Indoor oxygen saturation≥95%.
- •D. Cardiac Function: Left ventricular ejection fraction (LVEF) ≥40%.
- •The patients did not receive any antitumor treatments such as chemotherapy, radiotherapy and immunotherapy (such as immunosuppressive drugs) within 4 weeks before enrollment, and the toxicity related to previous treatments had returned to < 1 level at enrollment (except for low grade 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
- •Have a history of epilepsy or other central nervous system diseases.
- •Women who are pregnant (urine/blood pregnancy test positive) or lactating.
- •Male or female with a pregnancy plan in the next 1 year.
- •Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 year after enrollment.
- •Uncontrolled infectious disease within 4 weeks prior to enrollment.
- •Active hepatitis B/C virus infection.
- •HIV infected patients.
- •Suffering from a serious autoimmune disease or immunodeficiency disease.
- •The patient 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 corticosteroids within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids).
- •Suffering from mental diseases.
- •Patient has drug abuse/addiction.
- •According to the researcher's judgment, the patient has other unsuitable enrollment conditions.
研究组 & 干预措施
Third generation CAR-T cells
Experimental
Patients receive CD22 CAR-T cells transduced with a lentiviral vector on day 0 in the absence of disease progression or unacceptable toxicity.
干预措施: Third generation 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)
- Overall survival(3 years)
- Rate of anti-CD22 CAR-T cells in bone marrow cells and peripheral blood cells(3 years)
- Quantity of anti-CD22 CAR-T cells in bone marrow cells and peripheral blood cells(3 years)
- Quantity of anti-CD22 CAR copies in bone marrow cells and peripheral blood cells(3 years)
- Event-free survival(3 years)
- Relapse-free survival(3 years)
研究者
MEI HENG
Principal Investigator
Wuhan Union Hospital, China
研究点 (1)
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