Precise Design of Cell Therapy for Relapsed and Refractory Hematological Tumors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- adverse events.
研究概览
简要总结
This clinical trial aims to evaluate the efficacy and safety of CAR-T cell therapy in patients with relapsed/refractory hematologic malignancies.
详细描述
This clinical trial aims to evaluate the efficacy and safety of CAR-T cell therapy in patients with relapsed/refractory hematologic malignancies. The primary objective is to determine the maximum tolerated dose (MTD), safety profile, and the overall response rate (ORR) of CAR-T cells in these patients. Secondary objectives include assessing marrow remission rates and minimal residual disease (MRD) clearance at various time points (2 weeks, 1 month, 3 months, 6 months, and 1 year) in patients with bone marrow involvement, as well as evaluating the changes in multiple sites of involvement through PET-CT or PET-MRI before and one year after CAR-T therapy. The study will also track event-free survival (EFS), progression-free survival (PFS), and overall survival (OS) rates at 1, 2, 3, and 5 years post-treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with relapsed/refractory hematologic malignancies confirmed to express CD19, CD22, CD20, CD7, CD5, CD2, CD79b, BCMA, GPCR5D, CD38, CD33, CD123, CD133, CLL1, EBV (GP350, LMP1), CMV (Gb21, gB280...) or other validated targets (supported by domestic and international preclinical/clinical evidence) who meet the following criteria:
- •Male or female, aged ≥18 years and <75 years; Newly diagnosed patients with refractory disease (as defined by respective diagnostic criteria) after chemotherapy; Newly diagnosed patients with disease progression during chemotherapy and poor anticipated response to further chemotherapy; Patients with relapsed disease (≥1 recurrence) and confirmed residual tumor evidence; Patients with relapse after autologous or allogeneic hematopoietic stem cell transplantation (HSCT); Patients with relapse after CAR-T therapy; Patients with hematologic malignancies deemed incurable by current surgical, radiotherapy, or chemotherapy interventions.
排除标准
- •Patients meeting any of the following criteria will be excluded:
- •Life expectancy <12 weeks; Genetic testing reveals mutations or structural variants associated with the target antigens; Severe graft-versus-host disease (GVHD) requiring immunosuppressive therapy in post-HSCT relapse patients; Post-HSCT relapse <3 months with no available donor;
- •Organ dysfunction:
- •Serum creatinine >2.5 mg/dL; ALT/AST >5× upper limit of normal (ULN); Total bilirubin >2 mg/dL; Uncontrolled active infection; Active hepatitis B/C or HIV infection; Anticipated early loss to follow-up (<3 months post-treatment); Failure to provide signed informed consent or lack of ethics committee approval; Concurrent systemic conditions that may interfere with study participation; Other exclusion criteria deemed appropriate by the investigator.
研究组 & 干预措施
Precise Design of CAR-cell Injection
The drug for this trial is Precise Designof CAR- cells transduced with the lentiviral vector . The dose is 2x10e6 ~1x10e7 CAR-cell/kg in patients with relapsed/refractory hematologic malignancies.
干预措施: Cellular Therapy (Drug)
结局指标
主要结局
adverse events.
时间窗: 1 month
Type, incidence and severity of adverse events
Maximum tolerated dose
时间窗: 1 month
The maximum dose that does not cause death of the subject
Overall response rate
时间窗: 3 months
ORR in patients is defined as the rate of complete remission (CR, CRh)
次要结局
- Overall incidence and severity of adverse events.(12 months)
- Rate of relapse and refractory of Hematologic Diseases patients achieving MRD negative CR(12 months)