Dose-ranging Study of a Single Administration of T-cell Add-back Depleted of Host Alloreactive Cells in Patients Undergoing a Peripheral Blood Stem Cell Transplant From a Related, Haploidentical Donor
Phase I, Dose-ranging, Open-label, Study of a Single Administration of T-cells Add-back Depleted of Host Alloreactive Cells Using Theralux™ Therapy, Following Haploidentical Peripheral Blood Stem Cell Transplantation Submitted to CD34+ Cell Selection, in Patients With Severe Hematologic Malignancies
研究概览
地位
详细说明
Allogeneic stem cell transplantation is the treatment of choice for many patients with leukemia and other hematologic malignancies. However, a major limitation of this therapy is that for a significant number of patients no fully HLA-matched donor can be found. The application of partially HLA-matched (haploidentical) family donors, who are virtually always available, has some complications. If there is no T-cell add-back it increases the risk for life-threatening infections and disease relapse, while in case of T-cell add-back the risk of graft-versus-host disease is raised.
Kiadis Pharma has developed a method to selectively deplete host alloreactive T-cells through photodynamic therapy, using TH9402 ex vivo. The donor lymphocyte preparation depleted of functional alloreactive T-cells (ATIR) are administered to the patient 4-6 weeks after the stem cell transplant. This method enables early immune reconstitution while preventing graft-versus-host disease.
研究类型
注册 (实际的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
-
-
Quebec
-
Montreal、Quebec、加拿大、H1T 2M4
- Maisonneuve-Rosemont Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Any of the following hematologic malignancies: very high risk leukemia, acute leukemia, chronic myeloid leukemia (CML), lymphoma, multiple myeloma (MM), myelodysplastic syndrome (MDS)
- Incompatibility at two to three loci (HLA-A, B and/or DR) or a single DR locus of the unshared haplotype between the donor and recipient
- Life expectancy of at least 3 months
- Satisfactory performance status (ECOG ≤ 2);
Exclusion Criteria:
- Possibility of performing an allogeneic transplant with an HLA (human leukocyte antigen) matched sibling donor
- Availability of an 6/6 HLA-A, B and DRB1 matched unrelated donor within 2-3 months;
- Pregnancy
- Viral hepatitis (B or C)
- Active serious infectious process
- HIV positivity;
- Systemic dysfunction (cardiac, pulmonary, hepatic and renal) contra-indicating allogeneic stem cell transplantation
- Prior allogeneic transplantation
- Prior autologous transplantation within twelve months of baseline visit
- Any abnormal condition or laboratory result that is considered by the principal investigator capable of altering patient condition or study outcome
- Active central nervous system (CNS) disease at baseline
- Participation in a trial with an investigational agent within 30 days prior to entry in the study
- Malignant cells in circulating peripheral blood (> 25%)
- Other active malignant disease that would severely limit life expectancy
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:L1 (dose 1.0x10E4 T-cells/kg)
|
Single intravenous infusion
|
实验性的:L2 (dose 5.0x10E4 T-cells/kg)
|
Single intravenous infusion
|
实验性的:L3 (dose 1.3x10E5 T-cells/kg)
|
Single intravenous infusion
|
实验性的:L4 (dose 3.2x10E5 T-cells/kg)
|
Single intravenous infusion
|
实验性的:L5 (dose 7.9x10E5 T-cells/kg)
|
Single intravenous infusion
|
实验性的:L6 (dose 2.0x10E6 T-cells/kg)
|
Single intravenous infusion
|
实验性的:L7 (dose 5.0x10E6 T-cells/kg)
|
Single intravenous infusion
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Dose limiting toxicity, defined as acute graft-versus-host disease grade III or IV
大体时间:Within 30 days after ATIR infusion
|
Within 30 days after ATIR infusion
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Immune reconstitution
大体时间:Until 60 months after ATIR infusion
|
Until 60 months after ATIR infusion
|
Rate of disease relapse
大体时间:Until 60 months after ATIR infusion
|
Until 60 months after ATIR infusion
|
Occurrence and severity of graft-versus-host disease
大体时间:Until 60 months after ATIR infusion
|
Until 60 months after ATIR infusion
|
Occurrence of adverse drug reactions
大体时间:Until 18 months after ATIR infusion
|
Until 18 months after ATIR infusion
|
Incidence and severity of infections
大体时间:Until 18 months after ATIR infusion
|
Until 18 months after ATIR infusion
|
合作者和调查者
调查人员
- 首席研究员:Denis-Claude Roy, MD、Maisonneuve-Rosemont Hospital, Montréal, Canada
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.