A Phase II Study of Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Best Overall Response Rate (ORR)
研究概览
简要总结
The purpose of this research study is to determine how effective and how safe it is to give an Epstein-Barr Virus (EBV) immunotherapy product to participants with nasopharyngeal carcinoma (NPC) associated with EBV that has come back or spread to other parts of the participant's body. This is phase II study with the aim of establishing a baseline of efficacy.
详细描述
The study follows a pilot study optimizing and refining the manufacturing process, streamlining logistics (eg infusion protocol, enrolling out-of-town patients), increasing the cell dose, defining optimal patient eligibility, and improving monitoring for patients. Eligible participants will undergo a blood draw to obtain peripheral blood mononuclear cells (PBMCs) used for preparation of the immunotherapy product [estimated time 14-16 weeks]. Participants' PBMCs will be isolated by density centrifugation from peripheral blood and then infected with EBV to generate EBV-transformed B-lymphoblastoid cell lines (LCLs). LCLs will be irradiated and then used to stimulate autologous T cells, yielding an EBV-specific, autologous T cell product.
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
- •Histologically or cytologically proven NPC of an WHO grade, associated with EBV infection documented by the presence of EBER expression by in situ hybridization in the tumor. Positive EBER staining from another institution must be confirmed by pathology review at Brigham and Women's Hospital. Other confirmation of EBV-associated disease is acceptable, such as EBV DNA in situ hybridization, if EBER analysis is not adequate
- •Incurable NPC
- •Recovery from toxicity from any prior NPC therapy to grade 1 or better
- •18 years of age or older
- •Evaluable or measurable disease, according to modified RECIST
- •ECOG Performance Status of 0 or 1
- •Adequate bone marrow, liver and renal function as outlined in protocol
排除标准
- •Radiotherapy for primary NPC within 8 weeks of enrollment, or radiotherapy for any other reason within 6 weeks
- •Chemotherapy for NPC within 2 weeks of enrollment
- •Other cancer in the past 5 years, except for carcinoma in situ of the cervix or bladder, or non-melanomatous skin cancer
- •Uncontrolled central nervous system metastases
- •Active hepatitis, known HIV, or other condition that requires immunosuppressive therapy, including current use of high dose systemic corticosteroids
- •Autoimmune disease, such as systemic lupus erythematosis or rheumatoid arthritis, that is active and requires current immunosuppressive therapy
- •Active uncontrolled serious infection
- •Women of child-bearing potential who have a positive pregnancy test or are breast-feeding
结局指标
主要结局
Best Overall Response Rate (ORR)
时间窗: Restaging scans were performed every 8 weeks on treatment up to 20 weeks.
ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
次要结局
- Time to Progression (TTP)(Restaging scans were performed every 8 weeks until PD. Follow-up duration was up to 92 months.)
- Overall Survival (OS)(Participants were followed for survival per institutional practice until death or lost-to-follow-up. Follow-up duration was up to 92 months.)
- Number of Participants With Grade 1-2 Fatigue Adverse Events," as Accurate and Appropriate(Adverse events were assessed after each infusion treatment. Treatment duration was up to 66 months.)
研究者
Glenn J. Hanna
Principal Investigator
Dana-Farber Cancer Institute