A Single-Arm, Single-Center, Open-Label Pilot Study of Anti-ALPP CART-cells in Patient With Alkaline Phosphatase, Placental (ALPP)-Positive Advanced Solid Tumor
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Number of patients suffering treatment-related AE
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and efficacy of anti-ALPP chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating patients with ALPP-positive Advanced Solid Tumors.
详细描述
Primary Objectives:
To evaluate the number of ALPP-positive participants with treatment-related adverse events as assessed by CTCAE v4.0 after infusion with anti-ALPP CAR-T cells.
Secondary Objectives:
The number of patients experience objective response from anti-ALPP CAR-T cells treatment
To evaluate the progression-free survival (PFS) of anti-ALPP CAR-T cells in patients with ALPP-positive patients.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Expected to survive more than 3 months
- •Immunohistochemistry was confirmed to be mesothelin positive ALPP (higher than 50%)
- •Patients with no curative regimen to receive
- •WBC>3.5×1e+9/L,Hb>90g/L,PLT>75×1e+9/L
- •HBV DNA copy number less than 100/ml
- •ALT≤5ULN, AST≤5ULN, TB≤1.5ULN, ALB≥35g/L
- •Understand this test and have signed informed consent
排除标准
- •Autoimmune diseases, or any uncontrolled active disease that hinders participation in the trial
- •Decompensated liver cirrhosis, liver function Child-pugh C grade
- •Portal vein tumor thrombus, arterial portal fistula, hepatic arteriovenous
- •Long-term use of immunosuppressive agents after organ transplantation
- •Screening indicated that the target cell transfection rate was less than 30%
- •Invasive pulmonary embolism, deep venous thrombosis, or other major arterial / venous thromboembolic events occurred 30 days or 30 days prior to randomization
- •Subjects had an active or uncontrollable infection requiring systemic therapy 14 days or 14 days prior to randomization
- •Pregnant or lactating subjects
- •In the opinion of the investigator, the presence of a medical history or a history of mental state may increase the number of subjects associated with the risk factors associated with the study or study drug administration
- •Subjects who have signed a written consent or who are in compliance with the study procedure; or who are unwilling or unable to comply with the study
研究组 & 干预措施
CART treatment
Cyclophosphamide will be administered at dose of 20mg/kg for 1 day and then fludarabine will be given for the next 3 days with 35mg/m2 and then the CAR-T cells will be administered
干预措施: Retroviral vector-transduced autologous T cells to express anti-ALPP CARs (Drug)
结局指标
主要结局
Number of patients suffering treatment-related AE
时间窗: 1 year
To evaluate the number of ALPP-positive participants with treatment-related adverse events as assessed by CTCAE v4.0 after infusion with anti-ALPP CAR-T cells.
次要结局
- Objective response rate to ALPP-CART infusion(Eight weeks)
- Progression-free survival to ALPP-CART infusion(6 months)
- Number of peripheral CAR-T after infusion(6 months)
研究者
Qingzhu Jia, M.D.
Secretary
Xinqiao Hospital of Chongqing