An Exploratory Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of SY001 Injection Targets Mesothelin in a Single-arm, Dose-increasing Setting in Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Identification of Maximum Tolerated Dose (MTD)
研究概览
简要总结
Single-arm, dose-increasing setting study of CAR macrophages in Mesothelin overexpressing solid tumors.
详细描述
This study was a single-arm, single-center, dose-increasing design, using the "3+3" approach for dose escalation, to evaluate the safety, tolerability and initial effectiveness of SY001, and to evaluate the pharmacokinetic characteristics, cytokines and the correlation between the efficacy of SY001.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with pathologically diagnosed advanced ovarian cancer/pancreatic cancer who have failed at least 1 prior lines treatment, and tumor tissue samples were positive for mesothlin IHC staining;
- •According to the RECIST 1.1, there is measurable tumor lesions (non-lymph node lesion 10mm in length or lymph node lesion 15mm in diameter measured by CT or MRI, with scan layer thickness 5mm);
- •Eastern Cooperative Oncology Group (ECOG) score of 2 and satisfactory major organ functions;
- •Estimated life expectancy >3 months;
- •Female patients of childbearing age must undergo a serum pregnancy test at screening and prior to pretreatment and the results must be negative, and are willing to use a very effective and reliable method of contraception within 1 year after the last study treatment.
排除标准
- •Pregnant or lactating women;
- •Any uncontrollable active infection, including but not limited to active tuberculosis, HBV infection;
- •Patients who have a history of other mesothelin-targeting therapy;
- •Patients who have a history of autoimmune disease;
- •The investigator assessed that the patient was unable or unwilling to comply with the requirements of the study protocol.
研究组 & 干预措施
SY001 Targets Mesothelin positive solid tumors in a Dose-increasing Setting
Patients with mesothelin-positive ovarian cancer were treated with an SY001 injection in combination with an anti-PD-1 antibody. Patient 001 received 1109 SY001 CAR-pMACs via intravenous injection. Following a two-month period in which the treatment's safety was confirmed, this patient underwent another two does of 1109 SY001 cells on both day 1 and day 3. Prior to the CAR-pMACs infusion on day 1, a PD1 antibody Tislelizumab Injection was administered. In the case of the patient 002, SY001 treatment was delivered intravenously on three occasions: day 1, day 3, and day 5. The same as the first patient's protocol, Tislelizumab was given prior to the CAR-pMACs on day 1.
干预措施: SY001 (Drug)
结局指标
主要结局
Identification of Maximum Tolerated Dose (MTD)
时间窗: up to 28 days after SY001 infusion.
MTD will be determined based on DLTs observed during the first 28 days of study treatment.
次要结局
- Objective response rate (ORR)(3 months)
- Maximum Plasma Concentration of cytokines (Cmax)(1 month)
- Time to Peak (Tmax)(1 month)
- Area Under the Plasma Concentration Versus Time Curve (AUC)(1 month)
研究者
Xudong Wang
manager
Cell Origin Biotech (Hangzhou) Co., Ltd.