Prospective, Open-label, Multicentre Clinical Trial, Phase I/IIa, to Investigate the Safety and Tolerability of Allogeneic B-cell Concentrates CD3+-Depleted, CD19+-Enriched, Cryopreserved (Single Administration After Day 120 Following Allogeneic Stem Cell Transplantation (SCT), Donor-identical) in 4 Groups With Escalating Doses for Immune Response Enhancement, Measured as Response to a Antedated Single Vaccination
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of participants with EBV DNA copies/ml plasma higher than 50,000
研究概览
简要总结
The reconstitution of a functioning immune system after allogeneic stem cell transplantation takes months to years. Particularly memory B-lymphocytes reconstitute poorly with the current conditioning regimes. During the period of intense immune suppression the patients are extremely susceptible to bacterial, fungal and, most importantly, viral infections.The adoptive transfer of B-lymphocytes from the stem-cell donor might significantly enhance humoral immunity for the patient. Aim of the study is to evaluate a new cellular therapy with B-lymphocytes regarding safety. A booster vaccination after B-lymphocyte transfer will evaluate the functionality of the transferred B-lymphocytes in the patient.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients after allogeneic stem cell transplantation
- •Serostatus for EBV: R-/D- oder R+/D- oder R+/D+
排除标准
- •Serostatus for EBV: R-/D+
- •Severe acute Graft versus Host Disease (GvHD) (Glucksberg grade III und IV)
- •Chronic GvHD in middle- or high-risk group according to NIH staging
- •Rituximab administration after SCT
- •>10.000 EBV DNA copies/ml plasma
- •Recurrence of the haematological disorder needing therapeutic intervention
- •Secondary transplantation
- •SCT with transplant from a haploidentical donor
- •SCT with transplant from umbilical cord blood
- •CD34+-enriched transplant
- •in vitro T-cell depleted transplant
- •Pregnant or breast-feeding female
结局指标
主要结局
Number of participants with EBV DNA copies/ml plasma higher than 50,000
时间窗: for 120 days after administration of study medication
Number of participants with signs of a post-transplant lymphoproliferative disorder (PTLD)
时间窗: for 120 days after administration of study medication
Number of participants with adverse events (AEs), adverse reactions (ARs), serious adverse events (SAEs), serious adverse reactions (SARs) and suspected unexpected serious adverse reaction (SUSARs)
时间窗: for 120 days after administration of study medication
次要结局
- Change in the frequency of antibody-producing cells between dose groups(before and 7 days after preponed single vaccination)
- Change of Cytomegalovirus (CMV) DNA copies/ml plasma between dose groups(1 day before and up to 120 days after administration of study medication)
- Change of mean absolute number of B-lymphocytes, naïve B-lymphocytes and memory B-lymphocytes between dose groups.(1 day before and up to 120 days after administration of study medication)
- Change of antigen-specific antibody concentration in serum/plasma between dose groups(1 day before and up to 120 days after administration of study medication)
- Number of patients with >5,000 CMV DNA copies/ml plasma or with signs of organ infestation by CMV between dose groups.(up to 120 days after administration of study medication)