Multi-virus (Cytomegalovirus, EB virus, Adenovirus, BK virus, and HHV-6) specific Cytotoxic T-Lymphocytes from HLA-haploidentical or more HLA-matched relative donor to persistent viral infection after hematopoietic cell transplantation (multi-center, prospective phase I/II study) - Multi-virus specific CTL from HLA-haploidentical or more HLA-matched relative donor to persistent viral infection after HCT.

Medical Hospital, Tokyo Medical and Dental University0 个研究点目标入组 3 人开始时间: 2016年11月1日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1)ATG, Campath-1H or other anti-T cell monoclonal antibodies within 28 days before the entry. 2)Severe infectious diseases except for ADV, BKV, CMV, EBV, or HHV6 infection. 3)Donor lymphocyte infusion within 28 days before the entry 4)Uncontrollable acute GVHD (grade III-IV) despite standard immunosuppressive therapy (for example; prednisolone up to 0.5mg/kg/day) 5)Relapse of hematological malignancy that is considered as an indication for HSCT 6)History of malignancy, except for (1) the patients malignancy that is to be treated with HCT, (2) malignancy in remission for more than 5 years or (3) totally resected GI or skin cancer 7)SpO2 on room air < 90% 8)Patients with any of the following pulmonary function tests (PFT) results: i) FEV1/vital capacity < 70% for 16 years and older, and < 80% for age between 6 years and 15 years. ii) %VC <80% iii) FEV1 <75% of predicted with 10% decline compared before HCT. 9)Incidence of bronchiolitis obliterans (BO), or bronchiolitis obliterans syndrome (BOS) on high-resolution computed tomography. 10)KL-6 >500U/mL for patients 16 years and older, and >250U/mL for patients 15 years and under 11)Smoking after HSCT 12)Ejection fraction less than 40% 13)Patient judged not eligible for this study by the investigator.

发起方