A Multicenter Efficacy and Safety Study of Cluster of Differentiation 19 (CD19)-Targeted CART (CD19CART) Therapy for CD19 Positive Relapsed or Refractory B-cell Hematologic Malignancies (SCT019-01）
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Occurrence of study related adverse events
研究概览
简要总结
This single arm, open-label, multi-center clinical trial is studying CD19 targeted chimeric antigen receptor T cells therapy in treating patients with CD19 positive malignant B-cell derived leukemia and lymphoma that is relapsed (after stem cell transplantation or chemotherapy) or refractory to chemotherapy.
详细描述
This single arm, open-label, multi-center clinical trial is studying CD19 targeted chimeric antigen receptor T cells therapy in treating patients with CD19 positive malignant B-cell derived leukemia and lymphoma that is relapsed (after stem cell transplantation or chemotherapy) or refractory to chemotherapy. When patients enroll in this trial, autologous CD19CART cells were generated from the mononuclear cells of the patient's peripheral blood (PB). During the term of cell preparation of CD19CART cells, patients will receive a conditioning regimen. One day after completing conditioning regimen, the patient will be given infusions of CD19CART cells into the vein over a period of 1 to 3 days. Patients will be monitored for a response, toxic effects, and the expansion and persistence of circulating CD19CART cells.
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
- — 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed as CD19 positive refractory and relapsed B cell hematologic malignancies included acute lymphoblastic leukemia (ALL),chronic lymphocytic leukemia(CLL),non-Hodgkin's lymphoma(NHL)
- •not eligible or appropriate for auto-HSCT or allo-HSCT or relapsed after hematopoietic stem cell transplant(HSCT)
- •At least one measurable lesion defined as one lesion larger than 1.5cm or two lesion more than 1.0cm(for patients with NHL )
- •Age ≤60 years
- •Eastern Cooperative Oncology Group(ECOG) Performance status 0 to 2, Expected survival > 6 months
- •Left Ventricular Ejection Fraction (LVEF) > 50%
- •no history of other malignancies;
- •no other serious diseases which conflict with the treatment in the present trial
- •All patients should consent to adopt efficient contraception methods during the treatment and after the treatment. The pregnant tests of women who are in child bearing period should be negative before the treatment.
- •patients should understand and are willing to participate in the trial. Inform consent form is supposed to obtained before treatment
排除标准
- •Diagnosis or classification undefined
- •Those with primary central nervous system lymphoma or testicular leukaemia or lymphoma
- •Patients with a known history or prior diagnosis of epilepsia or other disease affecting the central nervous system, or serious mental diseases;
- •Patients who have secondary leukaemia or lymphoma after chemotherapy or radiotherapy for other malignancies
- •Active acute or chronic graft-versus-host disease (GVHD) requiring systemic therapy, concurrent use of immunosuppressant medications
- •Class III/IV cardiovascular disability according to the New York Heart Association Classification
- •Pregnant or lactating women(the safety of this therapy on unborn children is not known)
- •With active infection
- •Active hepatitis B, hepatitis C or syphilis infection
- •Patients use of systemic steroids within 2 weeks. Recent or current use of inhaled steroids is not exclusionary
- •Prior treatment with gene therapy product
- •Cluster of differentiation 3(CD3) positive cells<0.9x10^4/ml in peripheral blood (PB)
- •Organ function meeting following criteria: liver and renal function: alanine aminotransferase(ALT)/aspartate aminotransferase(AST) > 3 times the upper limit of normal, or bilirubin>2.0 mg/dl（34.2umol/L）, or creatinine >2.5mg/dl（221.0umol/L） ; hematopoietic function:Neutrophil count<1.0x10^9/L，hemoglobin<80g/L，platelet <50x10^9/L(for patients with NHL )
- •Any uncontrolled active medical disorder that would preclude participation as outlined
- •HIV infection
- •The researchers considered unsuitable to participate in this clinical study.
- •Patients with poor compliance
结局指标
主要结局
Occurrence of study related adverse events
时间窗: up to 12 months
次要结局
- Anti-leukemia or lymphoma responses to CD19CART cell infusions(up to 24 weeks)