NCT06951425尚未招募1 期
A Phase l, Open-Label, Dose-escalation Study to Evaluate the Safety, Tolerability and Antitumor Activity of TH027 CAR-T Cells (TH-CART-027) in Subjects With Relapsed or Refractory Solid Tumors
Shanghai Tongji Hospital, Tongji University School of Medicine1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Safety：Incidence and severity of adverse events (AEs)
研究概览
简要总结
This is a Phase l, Open-Label, Dose-escalation Study to Evaluate the Safety, Tolerabilityand Antitumor Activity of TH027 CAR-T Cell lnjection (TH-CART-027) in Subjects With Relapsed or Refractory 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.The patients were aged from 18 to 75 years old (including the cut-off value), and the gender was not limited;
- •2.The expected survival time was more than 12 weeks;
- •3.ECOG score was 0-2;
- •4.One of the following tumor types was confirmed by pathology: osteosarcoma, neuroblastoma, gastric cancer or lung cancer, and the positive rate of CD276 expression in tumor tissue was more than 30% by immunohistochemistry;
- •5.Patients with ineffective standard treatment methods (such as postoperative recurrence, chemotherapy, radiotherapy, and progression after targeted drugs);
- •6.According to RECIST 1.1, there was at least one measurable lesion (the longest diameter of solid lesion >=10 mm, or the short diameter of lymph node lesion >=15 mm);
- •7.The function of main organs was normal (white blood cell count >= 3 × 10^9 / L, neutrophil count >= 1.5 × 10^9 / L, hemoglobin >= 8.5g/dl, platelet count >= 80 × 10^9 / L and lymphocyte count at 1 × 10^9 / L (including) ~ 4 × 10^9 / L (inclusive);
- •8.The liver and kidney function and cardiopulmonary function meet the following requirements:
- •Urea and serum creatinine <= 1.5 × ULN；
- •Left ventricular ejection fraction >= 50%;
- •Baseline oxygen saturation >= 94%;
- •Total bilirubin <= 1.5 × ULN； ALT and AST <= 2.5 × ULN；
- •9.The patient or legal representative can fully understand the significance and risk of this trial and has signed the informed consent.
排除标准
- •1.Patients with history of immune deficiency or autoimmune diseases (including but not limited to rheumatoid arthritis, systemic lupus erythematosus, vasculitis, multiple sclerosis, insulin-dependent diabetes, etc.); Patients with graft-versus-host disease (GVHD) or need immunosuppressive agents;
- •2.There was a history of other second malignancies in 5 years before screening;
- •3.Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) were positive, and the peripheral blood HBV DNA titer was not within the normal reference value; HCV antibody and HCV RNA in peripheral blood were positive; HIV antibody positive patients; Syphilis was positive;
- •4.Severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification >= III), severe arrhythmia;
- •5.Unstable systemic diseases judged by researchers: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
- •6.Within 7 days before screening, there were active or uncontrollable infections requiring systemic treatment (except mild urogenital infection and upper respiratory tract infection);
- •7.Pregnant or lactating women, female subjects who plan to conceive within one year after cell transfusion, or male subjects whose partners plan to conceive within one year after cell transfusion;
- •8.Patients who had received CAR-T therapy or other gene modified cell therapy before screening;
- •9.The subjects who were receiving systemic steroid treatment within 7 days before the screening or who needed long-term systemic steroid treatment (except inhalation or local use) were determined by the researchers;
- •10.The ascites increased gradually after 2 weeks of conservative treatment (such as diuresis, sodium restriction, excluding ascites drainage);
- •11.According to the judgment of the researcher, it does not conform to the situation of cell preparation;
- •12.Other researchers think that it is not suitable for inclusion.
研究组 & 干预措施
Treatment of B7H3+ solid tumors
Experimental
Intraperitoneal Infusion for Ovarian Cancer and Peritoneal Metastatic Tumors; Intravenous Infusion for Other Types of Solid Tumors
干预措施: TH-CART-027 (Drug)
结局指标
主要结局
Safety：Incidence and severity of adverse events (AEs)
时间窗: Six months post CAR-T cells infusion.
To evaluate possible adverse events after TH-CAPT-027 infusion, including the incidence and severity of AEs.
Safety：Incidence of Dose Limiting Toxicity (DLT)
时间窗: 28 days after the first TH-CART-027 infusion.
Limiting toxicity type, incidence, and severity of dose limiting toxicities (DLTs) within 28 days after the first TH-CART-027 infusion
次要结局
- Overall survival (OS)(12 and 24 months post CAR-T cells infusion.)
- Objective response rate (ORR)(3 months post CAR-T cells infusion.)
- Progression Free Survival (PFS)(1 year post CAR-T cells infusion.)
- Disease Control Rate (DCR)(1 year post CAR-T cells infusion)
研究者
Aibin Liang
Professor, Chief Physician, Vice President of Tongji Hospital, Tongji University School of Medicine etc.
Shanghai Tongji Hospital, Tongji University School of Medicine
研究点 (1)
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