EUCTR2008-006649-18-GB进行中（未招募）1 期
CMV TCR Gene Therapy: A Phase I Safety, Toxicity and Feasibility Study of Adoptive Immunotherapy with CMV TCR-transduced Donor-derived T cells for Recipients of Allogeneic Haematopoietic Stem Cell Transplantation. - CMV TCR Gene Therapy (CMV TCR-001)
niversity College London0 个研究点目标入组 10 人开始时间: 2011年11月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion Criteria (Recipient):
- •1. Age: 18-65 years (inclusive)
- •2. Recipients of HLA-matched sibling Allo-HSCT for underlying haematological malignancies as per national and institutional guidelines.
- •3. HLA-A*0201 positive
- •4. CMV seropositive (anti-CMV IgG detectable pre-transplant)
- •5. Meets all other recipient criteria for Allo-HSCT as per institutional guidelines.
- •Inclusion Criteria (Donors)
- •1. Pre-selected HLA-matched sibling stem cell donor (as per institutional criteria)
- •2. Age: 16 years or older (inclusive)
- •3. HLA-A*0201 positive
- •4. CMV seronegative (no anti-CMV IgG detectable)
- •For further details of inclusion and exclusion criteria please see Clinical Trial Protocol.
- •Patients will be recruited to the study during their pre-transplant consultation and medical. Participants will only be eligible for the study if they are: (i) HLA-A*0201 positive (the TCR is HLA-A*0201 restricted and CMV pp65-specific) and (ii) CMV seropositive (CMV IgG detected) and their donor is: (i) an HLA-matched sibling/family member and (ii) CMV seronegative (CMV IgG not detected). All participants will be required to give signed, informed consent. A detailed explanation of the study rationale and risks will be given by the relevant PI. All patients will receive a patient information sheet and be given time to discuss the study with family and friends.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •(i) Pregnant or lactating women
- •(ii) Co-existing medical problems that would place the patient at significant risk of death due to GVHD or its sequelae
- •(iii) HIV infection
- •And to be assessed prior to CMV-specific T cell infusion (for confirmation prior to product release):
- •(i) Active acute GVHD > Grade I
- •(ii) Concurrent use of systemic corticosteroids
- •(iii) Organ dysfunction as measured by
- •ii.creatinine > 200 uM/l
- •iii.bilirubin > 50 uM/l
- •iv.ALT > 3x upper limit of normal
研究者
相似试验
暂停
1 期
Study of Adoptive Immunotherapy With Donor-derived CMV-specific T Cells for Recipients of Allo-HSCTHaematological MalignanciesCMV InfectionNCT02988258University College, London10
已完成
1 期
CMV-TCR-T Cells for CM Virus Infection After HSCTCMV Infection or Reactivation After Allogenic HSCTNCT04153279Hebei Yanda Ludaopei Hospital17
终止
1 期
A Dose-Escalation Study Evaluating Safety and Tolerability of Viral-Specific T Cells Against CMV in Adult Solid Organ Transplant RecipientsCytomegalovirus InfectionsSolid Organ TransplantNCT03950414University of Wisconsin, Madison2
已完成
2 期
V160 2-Dose and 3-Dose Regimens in Healthy Cytomegalovirus (CMV) Seronegative Females (V160-002)Cytomegalovirus (CMV) InfectionsNCT03486834Merck Sharp & Dohme LLC2,200
Unknown
1 期
CMV-TCR-T Cells for Refractory CMV Infection After HSCTAllogeneic Hematopoietic Stem Cell TransplantationCMV InfectionNCT05089838Xiao-Jun Huang12