A Phase I Trial of Vaccination With CT7, MAGE-A3, and WT1 mRNA-electroporated Autologous Langerhans-type Dendritic Cells as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Number of Participants Evaluated for Vaccine Safety
研究概览
简要总结
The purpose of this study is to see if the investigator can help the immune system to work against myeloma.
This study will see if a vaccine made with altered dendritic cells will make T cells work against tumor cells. The stem cells collected for the transplant will also be used to grow dendritic cells in the lab. The dendritic cells will carry the antigens. These cells then will be injected under the skin. The investigators will do lab studies before and after the vaccination to find out if the vaccine is working.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Symptomatic multiple myeloma, ISS stages I-III, within 12 months of starting therapy.
- •Completion of induction therapy with Very Good Partial Response (VGPR), or better, by International Myeloma Working Group (IMWG) criteria.
- •Deemed eligible for ASCT by standard institutional criteria.
- •Age ≥18 years.
- •Documentation of CT7, MAGE-A3, or WT1 expression in the bone marrow and/or bone marrow aspirate.
排除标准
- •Prior autologous or allogeneic SCT.
- •Previous immunization against CT7, MAGE-A3, other cancer-testis antigens, or WT
- •Known immunodeficiency, HIV positivity, hepatitis B, or hepatitis C.
- •History of autoimmune disease (e.g., rheumatoid arthritis, SLE), other than vitiligo, diabetes, or treated thyroiditis, which are allowed.
- •History of severe allergic reactions to vaccines or unknown allergens.
- •Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first immunization.
- •Lenalidomide-related toxicities before ASCT necessitating its discontinuation as part of treatment.
研究组 & 干预措施
Arm 1 Vaccine
This is a prospective, two-arm phase I randomized trial. Patients will be accrued only from and treated at MSKCCand The Rockefeller University/Center for Clinical & Translational Science . The study will assess autologous LCs presenting CT7, MAGE-A3, and WT1 after electroporation with CT7, MAGE-A3, and WT1 mRNA. Twenty patients will accrue to the study and ten will receive vaccines at 9x10^6 LCs per dose (i.e., combination of 3x10^6 CT7 mRNA-electroporated LCs + 3x10^6 MAGE-A3 mRNA-electroporated LCs + 3x10^6 WT1 mRNA-electroporated LCs) and another ten who will not receive any LC vaccines but will otherwise undergo identical cytoreduction, ASCT, and standard supportive care. At approximately 3 months after ASCT and as deemed clinically appropriate, patients will start lenalidomide maintenance therapy, which is now standard to delay disease progression.
干预措施: CT7, MAGE-A3, and WT1 mRNA-electroporated Langerhans cells ( LCs) (Biological)
Arm 2 control
Patients receive standard of care treatment after autologous stem cell transplant
干预措施: Standard of care (Other)
结局指标
主要结局
Number of Participants Evaluated for Vaccine Safety
时间窗: 1 year
Participants will be evaluated for the safety of the vaccine, monitored and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 for toxicity and adverse event reporting to the Food and Drug Administration. Dose limiting toxicity (DLT) is defined as grade 3 or higher toxicity. The only toxicities captured outside of the SAEs reported will be all grade 1-5 toxicites deemed definitely, probably, or possibly related to the vaccine portion of the study.
次要结局
- Median Progression Free Survival(Up to 7 years)