NCT06375187招募中1 期
A Phase I Study to Evaluate the Safety and Efficacy of Engineering Tumor Infiltrating Lymphocytes Injection (GC203 TIL)in Patients With Advanced Malignant Solid Tumors
Shanghai Juncell Therapeutics1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2024年5月29日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicity
研究概览
简要总结
A clinical trial to assess the safety and efficacy of engineered Tumor Infiltrating Lymphocytes (TIL) for the treatment of Advanced Malignant 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. In the opinion of the Investigator, patients must be able to sign the ICF and complete all study-required procedures.
- •2. Patients must be ≥18 and ≤75 years of age at the time of consent.
- •Patients with advanced metastatic solid tumors with clear pathological diagnosis have failed standard therapy (standard therapy is defined as existing guidelines and consensus recommended therapy [including but not limited to chemotherapeutic therapy, radiotherapy, mutation-targeted therapy, immunotherapy, and surgery]) , including but not limited to gynecological tumors (ovarian cancer, endometrial cancer, cervical cancer), breast cancer, gastrointestinal Cancer, lung cancer.
- •4. Patients have feasible tissue areas for tumor resection/puncture to generate GC203 TIL, the total volume of the tissue > 400mm3, and the lesion has not received local treatment (such as radiotherapy, radiofrequency therapy, oncolytic virus, etc.) or has progressed after local treatment;
- •At least one measurable target lesion before preconditioning, as defined by RECIST1.
- •6. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •7. Patients must have an estimated life expectancy of ≥3 months.
- •Patients must have the following hematologic parameters, Coagulation functions and hepatic and renal function:
- •Absolute Neutrophil Count (ANC)≥1.0×10^9/L;
- •Absolute Lymphocyte Count(ALC)≥0.5×10^9/L;
- •Platelet≥80×10^9/L；
- •International Normalized Ratio（INR）≤1.5×ULN;
- •Activated Partial Thromboplastin Time（APTT）≤1.5×ULN;
- •Serum Creatinine (Scr)≤1.5mg/dL (or 132.6μmol/L) or Creatinine Clearance≥60mL/min
- •Urinalysis: urine protein less than 2+, or 24-hour urine protein <1g;
- •Alanine aminotransferase(AST/SGOT) ≤3×ULN;
- •Alanine aminotransferase (ALT/SGPT) ≤3×ULN;
- •Total Bilirubin(TBIL)≤1.5×ULN；
- •Women of child-bearing potential (WCBP), must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study.
- •10. Patients must have no contraindications for surgery or biopsy.
- •Patients have good compliance and be able to adhere to research access plans and other protocol requirements.
排除标准
- •Participate in clinical trials of other drugs or biologic therapies within 4 weeks before enrollment;
- •Participants who have had a history of allogeneic T cell therapy; gene engineering autologous cell therapy within 1 years.
- •Patients who have received systemic antitumor therapy within 4 weeks.
- •Patients who have had another primary malignancy within the previous 5 years
- •Patients who have received a live or attenuated vaccination within 28 days prior to the start of treatment
- •Patients with a history of hypersensitivity to any component of the study drugs
- •Patients who are pregnant or breastfeeding.
研究组 & 干预措施
Treatment Arm
Experimental
Engineering Tumor Infiltrating Lymphocytes Injection (GC203 TIL)
干预措施: Engineering Tumor Infiltrating Lymphocytes (Biological)
结局指标
主要结局
Dose Limiting Toxicity
时间窗: Up to Day 28
Maximal Tolerance Dose
时间窗: Up to Day 28
Adverse Events
时间窗: Maximum 360 days
次要结局
- Progression-Free Survival(Every 6 weeks for 12 months)
- Objective Response Rate(Every 6 weeks for 12 months)
- Disease Control Rate(Every 6 weeks for 12 months)
- Duration of Response(Every 6 weeks for 12 months)
- Overall Survival(Every 6 weeks for 12 months)
- Quality of Life Assessment(Every 6 weeks for 12 months)
研究者
研究点 (1)
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