A Phase II Study of Active Immunotherapy With GRNVAC1, Autologous Mature Dendritic Cells Transfected With mRNA Encoding Human Telomerase Reverse Transcriptase, in Patients With Acute Myelogenous Leukemia in Complete Clinical Remission
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 12
- 主要终点
- Feasibility will be assessed by examining whether enough cells are collected during leukapheresis, whether enough vaccine is manufactured for at least 2 injections, and whether the patient is still in remission when the vaccine is released.
研究概览
简要总结
This is a phase II study to evaluate the safety, feasibility and efficacy of immunotherapy with GRNVAC1 in patients with AML.
详细描述
This is a multicenter, open-label evaluation of feasibility, safety and immunotherapy in patients with AML in complete clinical remission. Patients will undergo leukapheresis prior to or shortly after completing consolidation chemotherapy. Dendritic cells will be transfected with the messenger RNA encoding human telomerase reverse transcriptase (hTERT) and a portion of the lysosome-associated membrane protein LAMP-1 (LAMP), matured, aliquoted, and cryopreserved. The final autologous vaccine product is referred to as GRNVAC1. Patients will be vaccinated with weekly for 6 weeks,will "rest" for 4 weeks, then will receive 6 boost injections, each administered every other week for 12 weeks. Patients will be followed every 4 weeks until Week 54, then every 3 months for 1 year, then every 6 months up to approximately 5 years from the first vaccination or until relapse/progression.
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
- •AML in first complete remission (CR1) or in second complete remission (CR2) with CR1 >/= 6 months
- •Has completed at least one cycle of consolidation chemotherapy within past 6 months
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Adequate hepatic/renal function
排除标准
- •CR1 and good risk cytogenetic features [t(15;17), t(8;21), inv(16) or t(16:16)]
- •Central nervous system or leptomeningeal disease
- •Allogeneic stem cell transplant planned or expected
- •Documented allergy to penicillin or beta-lactam antibiotics
- •Active or ongoing autoimmune disease
- •Clinically significant pulmonary or cardiovascular disease
研究组 & 干预措施
GRNVAC1
Autologous dendritic cell vaccine
干预措施: GRNVAC1 (Biological)
结局指标
主要结局
Feasibility will be assessed by examining whether enough cells are collected during leukapheresis, whether enough vaccine is manufactured for at least 2 injections, and whether the patient is still in remission when the vaccine is released.
时间窗: 1 year
次要结局
- Immunological response, defined as the proportion of patients with a positive induction of hTERT-specific T cells to twice the pre-vaccination level, the proportion of patients with DTH, and event-free survival.(2 years)