Intravenous Injection of Oncolytic Virus Injection (RT-01) in Patients With Relapsed or Refractory T-cell Lymphoma
A Sing-Arm, Open Clinical Pharmacology Study of Intravenous Injection of Oncolytic Virus Injection (RT-01) in Patients With Relapsed or Refractory T-cell Lymphoma
研究概览
详细说明
This is an investigator initiated , single-arm, open-label clinical pharmacology study of RT-01 given via Intravenous injection in patients with advanced solid tumors. RT-01 will be administered on days 1 and 6, and every 8 weeks thereafter (up to 6 times).
This study is planned to enroll 6 patients with Relapsed or Refractory T-cell Lymphoma.
The purpose of this study is to assess the safety and tolerability, antitumor activity, The immunoreactivity, The immunogenicity, pharmacokinetics and virus shedding of RT-01.
研究类型
注册 (预期的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名:Zhou huan, MD
- 电话号码:13665527160
- 邮箱:zhouhuanbest@163.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Male or female aged ≥ 18 years.
- The following of typesRelapsed T-cell lymphoma (TCL): peripheral T-cell lymphoma (PTCL) [peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell (ALCL)], and cutaneous TCL (CTCL) of mycosis fungoides (MF).
- Patients have received at least 1-line systemic treatment in the past and who have relapsed or are refractory: failed to achieve complete remission (CR) or disease progression (PD) after CR, ineligible for autologous hematopoietic stem cell transplantation (ASCT) or PD after ASCT.
- There is at least one measurable lesion without previous local treatment, which the long axis of the intranodal lesion is >15 mm or extranodal lesion >10 mm According to Lugano 2014 criteria.
- Patients Eastern Cooperative Oncology Group (ECOG) physical status score must be 0 or 1.
- Life expectancy≥3 months et al.
Exclusion Criteria:
- Subjects with brain metastasis and/or clinically history tumor brain of metastasis;
- Subjects who have received anti-tumor therapy such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, etc within 2 weeks before RT-01 administration;
- Subjects who have participate in another interventional study within 4 weeks before RT-01 administration;
- Subjects who have had major surgery within 4 weeks before RT-01 administration.
- Patients in any condition requiring systemic treatment with corticosteroids (prednisone > 10 mg/day or equivalent of the similar drug) or other immunosuppressive agents within 14 days before RT-01 administration, but currently or previously treated with any of the following steroid regimens, were included: Topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids with minimal systemic absorption; Prophylactic short-term use of corticosteroids;
- Subjects who have participate in another oncolytic virus study within 8 weeks before RT-01 administration;
- Subjects received live vaccines within 7 days before RT-01 administration;
- Subjects received Antiviral drugs within 2 weeks, long-acting interferon within 4 weeks before RT-01 administration# 9.Subjects with adverse reactions caused by previous anti-tumor treatment not recovered to (CTCAE 5.0) grade 1 (except alopecia);
10.Subjects who have uncontrolled active infection; 11.Subjects with known positive history of human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome (AIDS); 12.Subjects who have active hepatitis; 13.Subjects who have serious cardiovascular system disorders history; 14.Clinically uncontrollable third space effusion,are considered unsuitable for this study in the opinion of the investigator; 15.Subjects with active autoimmune diseases or history of autoimmune diseases that may relapse; et al.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Oncolytic Virus Injection(RT-01)
RT-01 will be administered intravenously
|
RT-01 will be administered intravenously on day 1 and 6, and every 8 weeks thereafter (up to 6 times)
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
不良事件发生率
大体时间:长达 6 个月
|
根据 NCI CTCAE 5.0 版分级。
|
长达 6 个月
|
治疗期间免疫反应性的变化
大体时间:长达 28 天
|
外周血T淋巴细胞亚型
|
长达 28 天
|
评估 RT-01 的免疫原性
大体时间:长达 28 天
|
抗病毒抗体
|
长达 28 天
|
To evaluate objective Response Rate (ORR) of the antitumor activity
大体时间:Up to 2 years
|
To assessed per Lugano and Lyric
|
Up to 2 years
|
To evaluate the disease control rate (DCR) of the antitumor activity
大体时间:Up to 2 years
|
To assessed per Lugano and Lyric
|
Up to 2 years
|
To evaluate the viral shedding of RT-01
大体时间:8 weeks after last dose
|
Viral RNA
|
8 weeks after last dose
|
The Cmax of Viral RNA
大体时间:8 weeks after last dose
|
The maximum RNA peak concentration
|
8 weeks after last dose
|
The Tmax of Viral RNA
大体时间:8 weeks after last dose
|
The time of maximum RNA peak concentration
|
8 weeks after last dose
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Ohio State University Comprehensive Cancer CenterCelgene Corporation招聘中
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