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
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 6
- 主要终点
- To evaluate the disease control rate (DCR) of the antitumor activity
研究概览
简要总结
This is a single-arm, open-label, clinical pharmacology study to evaluate safety and efficacy of oncolytic virus injection(RT-01) in patients with Relapsed or Refractory T-cell Lymphoma. The purpose of this study is to evaluate the safety and tolerability, antitumor activity, The immunoreactivity, The immunogenicity, pharmacokinetics and virus shedding of RT-01.
详细描述
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Life expectancy≥3 months et al.
排除标准
- •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.
结局指标
主要结局
To evaluate the disease control rate (DCR) of the antitumor activity
时间窗: Up to 2 years
To assessed per Lugano and Lyric
To evaluate objective Response Rate (ORR) of the antitumor activity
时间窗: Up to 2 years
To assessed per Lugano and Lyric
The Tmax of Viral RNA
时间窗: 8 weeks after last dose
The time of maximum RNA peak concentration
Incidence of adverse events
时间窗: Up to 6 months
Graded according to the NCI CTCAE version 5.0.
The changes of the immunoreactivity during treatment
时间窗: Up to 28 days
Peripheral blood T lymphocyte subtype
To evaluate the immunogenicity of RT-01
时间窗: Up to 28 days
Antiviral antibody
To evaluate the viral shedding of RT-01
时间窗: 8 weeks after last dose
Viral RNA
The Cmax of Viral RNA
时间窗: 8 weeks after last dose
The maximum RNA peak concentration
次要结局
未报告次要终点
研究者
Zhang Feng, MD
Deputy Director of Hematology
First Affiliated Hospital Bengbu Medical College