A Phase I/II Study of Intratumoral Injection of the Small Molecule TLR8 Agonist VTX-2337 in Combination With Local Radiation in Low-Grade B-cell Lymphomas
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Celgene
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Number of Participants Whose Tumors Responded to Treatment With Intratumoral Injection of VTX-2337 in Combination With Low-Dose Local Radiation.
研究概览
简要总结
This study is to determine the safety and effectiveness of VTX-2337 (an investigational drug that stimulates the immune system) in combination with radiation therapy in treating patients with low-grade B-cell lymphoma. Patients will receive 2 low doses of radiotherapy, and 9 intratumoral injections of VTX-2337 over the course of 3 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •low grade B cell lymphoma
- •1 or more sites of disease appropriate for intratumoral injection
- •measurable disease other than the injection site
- •Performance Status of 1 or better
- •Adequate bone marrow, renal and hepatic function
- •No active autoimmune disease or systemic immunosuppressive drugs
- •Life expectancy > 4 months
排除标准
- •Known HIV
- •Known brain metastases
- •Malignancy within last 5 yrs (basal cell or non-invasive squamous cell carcinoma OK)
- •Anticoagulation therapy other than 325mg QD ASA
- •Significant cardiovascular disease
- •Pregnant or nursing
研究组 & 干预措施
VTX-2337 plus radiation
干预措施: VTX-2337 plus radiotherapy (Drug)
结局指标
主要结局
Number of Participants Whose Tumors Responded to Treatment With Intratumoral Injection of VTX-2337 in Combination With Low-Dose Local Radiation.
时间窗: Tumor assessment conducted at 12 weeks and every 3-6 months thereafter
Tumor response was assessed via CT scans of the chest, abdomen, pelvis or other medically appropriate imaging modality to evaluate all areas of disease. Cheson Criteria were used for calculation of response.
次要结局
- Assess the Safety and Feasibility of the Combination Regimen.(Safety assessed throughout study period.)