NCT07414316招募中1 期
A Single-Arm, Open-Label Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of GK01 Cell Injection in Subjects With Advanced Solid Tumors.
Beijing Geekgene Technology Co., LTD1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年2月13日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
A Single-Center, Open-Label Clinical Study to Evaluate the Safety, Preliminary Efficacy of GK01 Cell Injection in Subjects with Advanced Solid Tumors Refractory or Intolerant to Standard Therapy
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and sign a written informed consent document.
- •At the date of signing ICF, 18 ~75 years old, male or female.
- •Advanced lung cancer or esophageal squamous cell carcinoma confirmed by cytology or histopathology, failed or intolerant to standard therapy.
- •At least one measurable lesion that has not been irradiated or received other local therapies.
- •At least one measurable lesion remains (RECIST 1.1 criteria).
- •ECOG 0-1 points.
- •Expected survival time more than 3 months.
- •Adequate hematologic and organ function.
- •No absolute or relative contraindications to surgery, bronchoscopy, or percutaneous procedures.
排除标准
- •History of severe allergy, or hypersensitivity to any component of the drugs used in this study, including but not limited to lymphodepleting chemotherapy drugs, contrast agents for radiological examinations, and excipients of GK01 (such as dimethyl sulfoxide).
- •Any investigational drug or systemic anti-tumor therapy within 28 days prior to the start of lymphodepleting chemotherapy preconditioning, or within 5 half-lives of the previous drug.
- •Major surgery within 28 days prior to signing the ICF, or planned during the study period.
- •Toxicities from previous anti-tumor therapies have not recovered to ≤ Grade 1 or baseline level (according to NCI-CTCAE version 5.0) at the time of signing the ICF, with the exception of alopecia and hyperpigmentation.
- •Any uncontrolled active infection requiring parenteral antibiotic, antiviral, or antifungal therapy within 4 weeks prior to signing the ICF or before the first infusion.
- •History of or current active autoimmune disease that has the potential to recur (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, psoriasis, etc.), or subjects at such risk.
- •Prior history of bone marrow or organ transplantation.
- •Concurrent or prior history of interstitial lung disease or interstitial pneumonia.
- •History of active tuberculosis infection within 1 year prior to screening (subjects with a history of active tuberculosis infection more than 1 year ago may be enrolled if the investigator confirms there is no current evidence of active tuberculosis).
- •History of other primary malignancies within 5 years prior to the initiation of the study treatment.
- •Clinically significant cardiovascular disease.
- •History of bleeding within 6 months prior to signing the ICF.
- •Metabolic disorders, such as diabetes mellitus (with glycated hemoglobin [HbA1c] ≥8.5%), or other non-malignant organ or systemic diseases, or secondary reactions to cancer that may lead to high medical risk and/or uncertainty in survival assessment.
- •Central nervous system (CNS) metastases, leptomeningeal disease, or metastatic spinal cord compression; or a history of CNS disorders.
- •Live/attenuated or inactivated vaccine within 28 days prior to signing the ICF, or planned administration of a live/attenuated or inactivated vaccine during the screening period.
- •Systemic corticosteroid therapy (at a dose equivalent to or greater than 10 mg/day of prednisone) or other immunosuppressive medications within 14 days prior to tissue acquisition or during the study period.
- •Hepatitis B surface antigen (HBsAg) positivity; With negative HBsAg positive hepatitis B core antibody (HBcAb) ,and if peripheral blood hepatitis B virus (HBV) DNA positive; Hepatitis C virus (HCV) antibody positive and HCV RNA positive; Human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive; Both Treponema pallidum-specific and non-specific antibody tests are positive.
- •Female subjects who are pregnant or breastfeeding.
研究组 & 干预措施
Tumor-reactive T cells-GK01
Experimental
Autologous tumor-reactive T cells injection
干预措施: GK01 Injection (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: 2 years
The incidence and severity, and correlation of AEs (Adverse Events) and SAEs (Serious Adverse Events)
次要结局
- Count of TCR copies(2 years)
- Concentration of Cytokines(2 years)
- Percentage of Lymphocyte subsets(2 years)
- Circulating tumor DNA(2 years)
- Objective response rate (ORR)(2 years)
- Progression-free Survival (PFS)(2 years)
- Disease Control Rate (DCR)(2 years)
- Duration of Response (DOR)(2 years)
- Overall survival (OS)(2 years)
研究者
研究点 (1)
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