A Single-Arm, Single-Center, Open-Label Clinical Trial of Engineered T-Cell Therapy in Patients With ALPP-Positive Recurrent or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events of ALPP CAR-T cells [Safety and Tolerability]
研究概览
简要总结
This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of ALPP CAR-T cells in patients with ALPP-positive recurrent or metastatic solid tumors who have progressed after prior therapies. The primary objective is to determine the maximum tolerated dose (MTD), with a secondary aim to assess preliminary clinical efficacy in solid tumors.
详细描述
This study is designed as a single-arm, open-label, single-dose clinical trial to evaluate the safety and efficacy of ALPP CAR-T cell therapy in patients with recurrent or metastatic solid tumors. The study protocol consists of five main stages: (1) patient screening, (2) collection of peripheral blood mononuclear cells (PBMCs), (3) lymphodepletion chemotherapy, (4) ALPP CAR-T cell infusion, and (5) post-infusion follow-up.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must voluntarily provide written informed consent.
- •Aged 18-70 years (inclusive).
- •Life expectancy ≥ 3 months.
- •ECOG performance status 0-
- •Failed or unsuitable for standard therapy.
- •At least one measurable lesion per RECIST 1.
- •ALPP-positive tumor confirmed by immunohistochemistry.
- •Adequate organ and bone marrow function.
- •Effective contraception required for participants of childbearing potential.
- •Adequate venous access for leukapheresis.
排除标准
- •Primary CNS malignancy or uncontrolled CNS metastases.
- •Other malignancies within 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ).
- •Active autoimmune disease or history of autoimmune disease.
- •Immunodeficiency, including HIV positivity.
- •Bleeding disorders (inherited or acquired).
- •Clinically significant cardiovascular disease.
- •Active infection (including tuberculosis, hepatitis B/C, syphilis).
- •Pregnant or breastfeeding women.
- •History of refractory epilepsy, active GI bleeding, or high risk of tumor bleeding.
- •Severe systemic or psychiatric illness.
- •Prior cell or gene therapy.
- •Severe drug hypersensitivity history.
- •Investigator-assessed unsuitability for trial participation.
研究组 & 干预措施
Anti-ALPP CAR-T Cell Therapy
Biological: Anti-ALPP CAR-T Cells Following lymphodepletion chemotherapy, participants will receive anti-ALPP CAR-T cell infusion.
Drug: Fludarabine Drug: Cyclophosphamide
干预措施: Anti ALPP CAR-T cells treatment (Biological)
结局指标
主要结局
Incidence of Adverse Events of ALPP CAR-T cells [Safety and Tolerability]
时间窗: Up to 24 months
The incidence, type, and severity of all adverse events, serious adverse events, and abnormal laboratory findings.
Incidence of Dose Limiting Toxicity of ALPP CAR-T cells [Safety and Tolerability]
时间窗: Up to 1 month
Incidence of Dose Limiting Toxicity
次要结局
- Efficacy of ALPP CAR-T cells(Up to 24 months)
研究者
Haifeng Qin
Professor
Beijing GoBroad Hospital