NCT04477772已完成1 期
A Phase I Clinical Study of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) in Patients With Recurrent/Refractory Malignant Lymphoma
Shanghai Junshi Bioscience Co., Ltd.1 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2020年7月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Number of participants and severiaty with treatment-related Adverse events as assessed by CTCAE V5.0
研究概览
简要总结
A First-in-human, dose-escalation, dose-expansion phase I clinical study of JS004 in subjects with recurrent/refractory malignant lymphoma in China, to evaluate the safety, tolerbility, PK, immunogenicity,antitumor activity and biomarkers of JS004, to define MTD and RP2D of JS004. A cycle is 21 days(3 weeks) which includes JS004 being administered IV Q3W and JS004 combine with JS001 being administered IV Q3W. All patients will be treated until disease progression per Lugano response critieria 2014 for Lymphoma or intolerable toxicity per CTCAE 5.0, withdrawal of consent, or end of the study, whichever occurs first. Disease progression must be confirmed at least 4 weeks but no longer than 8 weeks after initial documentation of progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •1.Able to understand and sign informed consent voluntarily
- •2.18-70 years old
- •3.Pathologically confirmed malignant lymphoma
- •4.ECOG PS: 0-1
- •5.Expected survival ≥12 weeks
- •6.At least one measurable lesion per Lugano response critieria 2014 for Lymphoma
- •7.Adequate organ and marrow function, as defined below:
- •ANC≥1.5×109/L;
- •PLT≥100×109/L and ≥75×109/L for subjects with bone marrow involvement;
- •TBIL≤1.5 ULN, ≤2 ULN in those with hep109atic metastasis, except subjects with documented Gilbert's syndrome who must have a baseline conjugated bilirubin ≤3.0 mg/dL;
- •AST and ALT≤2.5 ULN, ≤5 ULN in those with hepatic metastasis;
- •Cr≤1.5 UL, or creatinine clearance≥50mL/min for subject;
- •INR ≤2 ULN and aPTT≤1.5×ULN for those with no prior anticoagulant therapy.
- •8.According to Fridericia's principle, QTC results need to match : Male≤450 ms，Female≤470 ms
- •9.Females of childbearing potential need to use effective contraception
排除标准
- •Patients with known allergy to macromolecular protein preparations or JS004 components
- •Prior exposure to anti-BTLA or anti-HVEM antibodies
- •Enrolled in other clinical studies within 4 weeks prior to the first dose of study treatment
- •Major surgery within 4 weeks prior to the first dose of study treatmentor still recovering from prior surgery
- •Patients who discontinued previous immunotherapy due to immune-related adverse reactions
- •Immunosuppressive agents have been used within 4 weeks prior to the first dose of study treatment
- •Prior allogeneic bone marrow transplantation or solid organ transplantation
- •Live attenuated vaccine be administered 30 days before the first dose of study treatment
- •Two or more malignancies developed within 5 years prior to first dose of study treatment
- •The patients have symptomatic, untreated, or requiring ongoing treatment central nervous system (CNS) metastases
- •Unresolved toxicities from prior anticancer therapy, defined as having not resolved to baseline or to NCI-CTCAE v5.0 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria with the exception of alopecia.Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by TAB004 may be included (e.g., hearing loss) after consultation with the medical monitor.
- •Autoimmune disease within the previous 2 years
- •A history of rapid allergic reaction, eczema, or asthma beyond the control of topical corticosteroids
- •A history of primary immunodeficiency
- •Concomitant disease that is not under control, including but not limited to: persistent or active infection, unexplained fever > 38.5°C, or heart disease, active peptic ulcer disease or gastritis
- •A history of active inflammatory bowel disease
- •Patients with evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- •Pregnant or lactating woman
- •Patients with vitiligo, alopecia, and hormonal replacement therapy have controlled endocrine defects
- •Any other medical factors that may affect subjects' rights, safety, compliance, ability to sign informed consent, and interpretation of study results.
- •Have a history of psychotropic drug abuse and unable to withdraw or have mental disorders.
结局指标
主要结局
Number of participants and severiaty with treatment-related Adverse events as assessed by CTCAE V5.0
时间窗: 2 Years
Safety and Tolerability
次要结局
- Objective Response Rate (ORR) per Lugano response critieria 2014 for Lymphoma(2 Years)
- Progrssion-free survival (PFS) per Lugano response critieria 2014 for Lymphoma(2 Years)
- Duration of Response (DOR) per Lugano response critieria 2014 for Lymphoma(2 Years)
- Disease Control Rate (DCR) per Lugano response critieria 2014 for Lymphoma(2 Years)
研究者
研究点 (1)
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