NCT02763254终止2 期
A Phase 2 Open Label Study to Investigate the Safety and Clinical Activity of Autologous EBV-specific T Cells (CMD-003) for the Treatment of Patients With EBV Positive Lymphomas
Cell Medica Ltd2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2016年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Best Overall Response
研究概览
简要总结
To investigate the efficacy of autologous Epstein-barr virus (EBV)-specific T cells for the treatment of EBV positive Diffuse Large B Cell Lymphoma (DLBCL), Hodgkin Lymphoma (HL) and Post-transplant Lymphoproliferative Disease (PTLD) after failing first line treatment.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study will include three primary cohorts, with any of the following EBV+ diseases:
- •Cohort A - DLBCL, 1) in first or subsequent relapse, not eligible for autologous transplantation following salvage therapy OR 2) relapse following autologous transplantation.
- •Cohort B - HL, brentuximab vedotin (BV) treatment failure or unable to tolerate BV.
- •Cohort C - PTLD, rituximab treatment failure.
- •Presence of active lymphoma or active PTLD, based on imaging performed within the previous 3 months.
- •Tumor positive for EBV encoded RNA (EBER) based on report from certified laboratory.
- •Absolute lymphocyte count (ALC) >500/µL
- •Male or female ≥ 12 years of age
- •Weight ≥ 35 kg
- •Eastern Cooperative Oncology Group (ECOG) performance score 0-2, inclusively or Lansky score ≥ 60, as age appropriate
- •Able to understand and comply with the requirements of the study and to provide written informed consent or age appropriate assent for pediatric patients.
排除标准
- •Known central nervous system (CNS) lymphoma
- •Primary refractory HL or DLBCL
- •Bulky disease
- •Relapse or progression following previous autologous EBV specific T cell treatment.
- •Use of systemic corticosteroids > 0.5 mg/kg/day prednisolone or equivalent does of alternative corticosteroid within 10 days prior to obtaining 200 mL starting material
- •Positive for HIV, hepatitis B, hepatitis C, syphilis or human T cell leukemia virus (HTLV).
- •Patient is pregnant or lactating
- •Systemic fungal, bacterial, viral or other infection that is not controlled
- •Prior allogeneic hematopoietic stem cell transplantation (allo HSCT)
- •Known history of primary immunodeficiency
研究组 & 干预措施
baltaleucel-T
Experimental
Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks.
干预措施: baltaleucel-T (Biological)
结局指标
主要结局
Best Overall Response
时间窗: 1 year
Best single observed response, complete response (CR) or partial response (PR) per Lugano 2014 Disease Response Criteria, during 12 month follow-up.
次要结局
- Adverse Events(1 year)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A Study of the Safety and Efficacy of EBV Specific T-cell LinesEpstein-Barr Virus InfectionsLymphomaPost-Transplant Lymphoproliferative DisorderNCT02580539Dr. Jean-Sebastien Delisle, MD, PhD12
终止
2 期
Cellular Immunotherapy Treatment Antigen-Directed for EBV LymphomaLymphoma, Extranodal NK-T-CellEBVNCT01948180Cell Medica Ltd15
撤回
2 期
Safety and Effectiveness of EBV-specific Cytotoxic T Cells for the Treatment for EBV Lymphomas or Other EBV-associated MalignanciesEBV LymphomasEBV-associated MalignanciesNCT03988582Memorial Sloan Kettering Cancer Center
已完成
1 期
EBV-TCR-T Cells for EB Virus Infection After HSCTEBV Emia and EBV Positive PTLD After Allogenic HSCTNCT04156217Hebei Yanda Ludaopei Hospital18
进行中（未招募）
2 期
A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)2024-512903-38-00Autolus Limited17