NCT06515314招募中1 期
A Phase 1, Single-arm, Open-label, Dose-escalation Study of AFP Specific T Cell Receptor Transduced T Cells Injection（HRYZ-T102）in Patients With AFP Positive Advanced Hepatocellular Carcinoma and Other Solid Tumors
Shanghai Ruiliyuan Biotechnology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年10月17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
- 12
- 试验地点
- 1
- 主要终点
- Adverse events and serious adverse events
研究概览
简要总结
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of HRYZ-T102 TCR-T Cell in patients with AFP positive advanced hepatocellular carcinoma and other solid tumors refractory to prior systematic treatments.
详细描述
This study plans to enroll 12-24 patients to assess the safety of HRYZ-T102. Subjects who meet the eligibility criteria will receive a single dose of HRYZ-T102 injection .The patient will be followed up 24 months.
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
- •The patient must be willing to sign the informed consent form.
- •Age ≥18 years and ≤75 years.
- •HLA-A 02:03 allele positive
- •Histologically-confirmed AFP positive hepatocellular carcinoma (HCC) or other solid tumor, No benefits from curative surgery or other local therapies are expected ,at least one prior line of systematic treatment at screening, judged by investigators.
- •Fresh samples or formalin-fixed paraffin-embedded (FFPE) samples, immunohistochemistry (IHC)-stained AFP positive or serum AFP ≥400ng/ml.
- •Barcelona Clinic Liver Cancer (BCLC) stage C or B and Child-Pugh ≤7
- •ECOG performance status ≤
- •Estimated life expectancy ≥4 months.
- •Patients must have at least one measurable lesion defined by RECIST 1.
- •Patients with any organ dysfunction as defined below:
- •Leukocytes≥3.0 x 10^9/L; blood platelets ≥75 x 10^9/L; hemoglobin≥85g/L; Absolute lymphocyte count≥0.8 x 10^9/L Serum albumin ≥ 30g/L; total bilirubin≤3×ULN; ALT/AST≤3×ULN ; Creatinine clearance ≥50mL/min; or serum creatinine ≤1.5×ULN; INR≤1.5×ULN; APTT≤1.5×ULN; LVEF≥50%; SpO2≥92%.
- •Subjects with potential fertility must agree to use effective contraceptive methods during the whole trials period and at least 1 year after receiving HRYZ-T102 cell transfusion treatment. HCG test for female with potential fertility must be negative within 7 days before apheresis.
排除标准
- •Toxicity of previous treatment has not been mitigated or ≤ Grade 1 at screening.
- •Another primary malignancy within 5 years (with some exceptions for completely-resected early-stage tumors)
- •With severe cardiovascular disease or presence of clinically-relevant central nervous system (CNS) disorders in six months before screening.
- •Systematic autoimmune disorders requiring long-term systematic immunosuppression
- •Have a history of hypersensitivity to cyclophosphamide or fludarabine, and it is known that any ingredient used in the treatment of this study will produce allergic reactions.
- •Current presence of or previously with hepatic encephalopathy
- •Organ transplanters and allogeneic cell transplanters.
- •Have a history of gastrointestinal bleeding or a definite tendency to gastrointestinal bleeding within 3 months before screening
- •Hereditary or acquired bleeding (e.g. coagulation dysfunction) or a tendency to clot
- •Subject has active infection or unexplained fever during screening and prior to cell transfusion
- •Have central nervous system metastasis with symptoms
- •Known HIV or syphilis infection, and/or active hepatitis C virus infection.
- •HBV infect subjects with HBV-DNA≥2000IU/ml
- •Pregnant or lactating female, or those whose HCG test is positive before enrollment.
- •Known uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease or liver failure
研究组 & 干预措施
HRYZ-T102 Injection
Experimental
Patients will undergo lymphocytapheresis, then treatment with HRYZ-T102 TCR-T cells.
干预措施: AFP Specific T Cell Receptor T Cells (Biological)
结局指标
主要结局
Adverse events and serious adverse events
时间窗: 2 years
Incidence of adverse events and serious adverse events
DLT
时间窗: 2 years
Dose-limiting toxicity
次要结局
- Concentration of Cytokines (IL-2、IL-6、IL-10、TNFα、IFNγ)(2 years)
- Objective Response Rate（ORR）(2 years)
- Duration of response (DoR)(2 years)
- Overall Survival (OS)(2 years)
- Disease Control Rate (DCR)(2 years)
- Time to response (TTR)(2 years)
- Progression-Free Survival（PFS）(2 years)
- Duration of TCR T cells in-vivo persistence(2 years)
研究者
研究点 (1)
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