Clinical Study on the Safety and Efficacy of CAR-T/CAR-NK Cells in the Treatment of Recurrent Refractory or Unresectable Solid Tumors
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
To investigate the safety and efficacy of CAR-T/CAR-NK cells in patients with recurrent or unresectable solid tumors, including pancreatic cancer, prostate cancer, breast cancer, glioma, etc
详细描述
To investigate the safety and efficacy of CAR-T/CAR-NK cells in patients with recurrent or unresectable solid tumors, including pancreatic cancer, prostate cancer, breast cancer, glioma, etc.
The study was divided into five stages: screening period, single harvest period, pretreatment chemotherapy period, treatment period, observation and follow-up period after treatment.
Subjects were pretreated with FC regimen before transfusion, and the subjects who met the infusion conditions were given CAR-T/CAR-NK cell infusion 1 ~ 2 days after the completion of eluent chemotherapy. The CAR-T/CAR-NK dose is calculated according to the patient's body weight, and the total number of cells transfused is about 1-2x106 /kg. Single intravenous infusion.
The efficacy was evaluated according to the evaluation criteria for solid tumors (RECIST1.1 selection).
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
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recurrent or unresectable solid tumors (including pancreatic, prostate, breast, glioma, etc.).
- •Age over 15 and under
- •KPS≥50 or ECOG score ≤2 and expected survival greater than 3 months.
- •No systemic therapy (except systemic immune checkpoint suppression or activation therapy) for at least 2 weeks or at least 5 drug half-lives (whichever is shorter) prior to apheresis.
- •The absolute number of neutrophils was > 1.0x109 /L.
- •Absolute number of platelets > 50x109 /L.
- •Absolute number of lymphocytes ≥ 0.2x109 /L.
- •ALT/AST < 3 times normal value.
- •Total bilirubin < 1.5mg/dl.
- •Creatinine < 2.5mg/dl, or creatinine clearance ≥60 mL/min/1.73 m
- •The ejection fraction of heart ≥ 45%, echocardiography examination centerless fluid, electrocardiogram normal
- •Blood oxygen saturation ≥92% under normal environment.
- •Women of childbearing age who had a negative urine pregnancy test before dosing began and agreed to take effective contraception during the trial until the last follow-up visit.
- •Volunteer to participate in this experiment and sign the informed consent.
排除标准
- •Those who are expected to survive less than 3 months. 2) Patients whose disease progression was so rapid that a complete treatment cycle could not be ensured at the time of enrollment as determined by the investigator.
- •Patients with primary tumors other than melanoma skin cancer (unless cured for more than 3 years).
- •Patients with infections including fungal, bacterial, viral or other uncontrolled infections or those requiring level 4 isolation.
- •HIV, HBV, HCV positive patients. 6) Patients with central nervous system diseases including stroke, epilepsy, dementia or autoimmune central nervous system diseases.
- •Myocardial infection, cardiac angiography or stenting, active angina pectoris or other significant clinical symptoms, or cardiogenic asthma or cardiovascular plasma cell infiltration in the 12 months prior to enrollment.
- •Those who are receiving anticoagulation therapy or have severe coagulation dysfunction.
- •The drug treatment that the patient is receiving will affect the safety and efficacy study of this project according to the judgment of the investigator.
- •Patients with allergy or history of allergy to the biologics used in this project.
- •Pregnant or lactating women. 12) Systematic use of systemic or systemic steroid drugs within 2 weeks prior to treatment (except those who have recently or currently used inhaled steroids).
- •The efficiency of T cell transduction by replication-deficient lentivirus was less than 30%, or the ability to expand in response to CD3 / CD28 costimulatory signals was insufficient (<5 times).
- •Those who have other uncontrolled diseases that the researchers consider unsuitable for enrollment.
- •Any situation that the investigator believes may increase the risk to the subject or interfere with the test results.
- •Patients who are also participating in other clinical studies.
结局指标
主要结局
PFS
时间窗: 2024.11
The time from the start of a randomized clinical trial until tumorigenesis (any aspect) progresses or death from any cause.
ORR
时间窗: 2024.11
Proportion of patients with PR or CR.
次要结局
未报告次要终点