EUCTR2021-006367-26-GR进行中（未招募）1 期
Phase I / II study of HLA-G + induced T-regulatory cells (iG-Tregs) in patients after allogeneic hematopoietic stem cell transplantation from HLA compatible sibling / donor. - IGTRegs
?a?ep?st?µ?? ?at???0 个研究点目标入组 26 人开始时间: 2022年10月17日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 26
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
- •1.Allogeneic Hematopoietic Cell Transplantation (Allo-HCT) from a fully HLA compatible donor sibling.
- •2. All of the following should be met during the initial evaluation assessment and the day of the iGTreg injection in case the iGTreg injection day is delayed> 14 days after the initial evaluation
- •a) Operating status: Karnofsky = 60%
- •b) Adequate hematopoiesis and organ function, in evaluation of the last 6 weeks:
- •c) Negative pregnancy test within 28 days of inclusion in the study (valid only for women of childbearing potential) AND before iG-Tregs injection
- •3. Consent to use effective contraception during the transplant period (only applies to sexually active women of childbearing potential and men)
- •4. Ability to understand and willingness to sign the informed consent form
- •5. The patient should be on constant prophylaxis of CsA (from day -3) at therapeutic levels (> 200 ng / ml) prior to admission.
- •1. The donor will be evaluated and meet the requirements according to the procedures of the institution and according to the JACIE standards to undergo leukophase (donor lymphocytes) without stimulation with G-CSF.
- •2. The donor should have the ability to understand and be willing to sign a written consent upon information specifically for this study.
- •3. Age 16-75 years
- •4. Body weight> 40 kg and good general health
- •5. HLA-fully compatible brother who is also the donor of the participating patient's hematopoietic stem cells
- •6. Negative pregnancy test (valid only for women of reproductive age)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1. Grade aGvHD =II (according to the criteria listed in Annex 1) or receiving systemic first-line treatment for the purchase of aGvHD. Stage II of GvHD skin (Grade I) is allowed.
- •2. Patients with signs of Residual Disease in their last hematological evaluation.
- •3. Uncontrolled infections that do not respond to treatment. Prophylactic treatment to reactivate CMV or EBV in the absence of evidence of CMV or EBV disease.
- •4. HBV, HCV or HIV positive individuals
- •5. Taking any research agent = <28 days before iG Treg injections. Non-indicative agents administered after transplantation (eg valcyte for CMV activation, MMF for GvHD prophylaxis) are allowed.
研究者
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