NCT07351903招募中1 期
The Single-arm Open-label Clinical Study Evaluating the Use of GK01 Cell Injection in Combination With or Without Chemotherapy for the Adjuvant Treatment of Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 15
研究概览
简要总结
This study is an open-label, single-arm clinical trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of GK01 in patients with advanced solid tumors.
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
- •Ability to understand and sign a written informed consent document.
- •At the date of signing ICF, 18 ~70 years old, male or female.
- •Patients with solid tumors confirmed by histopathology (including but not limited to pancreatic cancer, cholangiocarcinoma, gastric cancer, etc.) who are judged by investigator to be capable of undergoing radical total resection of the primary tumor for the purpose of cure.
- •No treatment for the primary tumor was received before surgical resection (no induction therapy or recurrent disease).
- •The expected survival time is more than 12 weeks;.
- •ECOG 0-1 points.
排除标准
- •Inoperable or metastatic (Stage IV) solid tumors.
- •Central nervous system (CNS) metastasis, leptomeningeal disease, or metastatic spinal cord compression; or a history of CNS disorders, including but not limited to epilepsy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, etc.
- •History of bone marrow or solid organ transplantation.
- •History of other primary malignancies within 5 years prior to study treatment
- •Hepatitis B surface antigen (HBsAg) positivity; With negative HBsAg but 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.
- •Allergy to any components of the drugs planned.
- •Previous radiotherapy within 28 days before signing the ICF.
- •History of active tuberculosis infection within 1 year before screening.
- •Concurrent or previous history of interstitial lung disease or interstitial pneumonia; presence of chronic lung disease or other respiratory conditions that significantly impair lung function.
- •Diagnosis of active autoimmune disease or a history of autoimmune disease that may recur (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, psoriasis, etc.), or at risk of such conditions.
- •Investigator-assessed clinically significant thyroid dysfunction.
- •Cardiovascular diseases with clinical significance.
- •No contraindications to curative resection of the primary tumor.
- •Attenuated or inactivated vaccines within 28 days before signing the I form, or planned administration of such vaccines during the screening period.
- •Comorbidities or other conditions are likely to affect protocol compliance or suitability for participation in this study.
- •Female subjects who are pregnant or breastfeeding.
研究者
相似试验
招募中
1 期
U69-CART-Cells For R/R T-ALLNCT07350863The First Affiliated Hospital of Soochow University12
尚未招募
1 期
A Hypoxia-Inducible CAR-T Cell Targeting AXL and CD73 for Advanced Gastric CancerNCT07333573Shanghai Zhongshan Hospital42
尚未招募
3 期
Pharmacokinetics, Safety, and Tolerability of GOPRELTO and NUMBRINO in Pediatric Nasal ProceduresNCT07287735Omnivium Pharmaceuticals LLC40
招募中
2 期
A Clinical Study to Assess Sutacimig in Participants With Congenital Factor VII DeficiencyNCT07347249Hemab ApS18
招募中
1 期
A Phase 1/2 Study of GW5282 in Participants With Advanced Solid TumorsNCT07328217Dizal Pharmaceuticals203