NCT05095649Unknown2 期
Phase II Trial of Donor Regulatory T-cells for Steroid-Refractory Chronic Graft-versus-Host-Disease in Patients Who do Not Obtain Complete Remission With Ruxolitinib
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2022年3月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
Phase II clinical trial to assess the efficacy of donor regulatory enriched T cells in steroid-refractory chronic graft versus host disease patients who did not obtain complete remission under treatment with ruxolitinib
详细描述
A number of 15 patients will be included to assess the efficacy of donor regulatory enriched T cells in steroid-refractory chronic graft versus host disease patients who did not obtain complete remission after 12 weeks of treatment with ruxolitinib.
The doses of Treg-enriched cells will be 2x10^6 cells/kg.
Survival at 1 year after Treg infusion will be represented based on the clinical data with Kaplan Meier curves.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipient of allogeneic hematopoietic stem cell transplantation
- •Participants must have steroid-refractory cGVHD and had obtained any response other than progression after at least 12 weeks of treatment with ruxolitinib. Steroid-refractory cGVHD is defined as having persistent signs and symptoms of cGVHD despite the use of prednisone at ≥ 0.25 mg/kg/day (or 0.5 mg/kg every other day) for at least 4 weeks (or equivalent dosing of alternate glucocorticoids) without complete resolution of signs and symptoms.
- •Stable dose of glucocorticoids for 4 weeks prior to enrollment.
- •No addition or subtraction of other immunosuppressive medications (e.g., calcineurin-inhibitors, sirolimus, mycophenolate-mofetil) for 4 weeks prior to enrollment. The dose of immunosuppressive medicines may be adjusted based on the therapeutic range of that drug.
- •No age limit. In the case of children participating in the study, the informed consent will be signed by a parents or legal guardians.
- •Eastern Cooperative Oncology Group scale performance status 0-2
- •Participants must have adequate organ function
- •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Ongoing prednisone requirement >1 mg/kg/day (or equivalent).
- •Concurrent use of calcineurin-inhibitor plus sirolimus (either agent alone is acceptable).
- •History of active thrombotic microangiopathy, hemolytic-uremic syndrome or thrombotic thrombocytopenic purpura in the last 6 months.
- •New immunosuppressive medication in the 4 weeks prior to enrollment.
- •Extra-corporeal Photopheresis or rituximab therapy in the 4 weeks prior to enrollment.
- •Post-transplant exposure to T-cell or interleukin-2 targeted medication within 100 days prior to enrollment.
- •Donor lymphocyte infusion within 100 days prior to enrollment.
- •Active malignant relapse.
- •Active uncontrolled infection.
- •Organ transplant (allograft) recipient.
- •HIV-positive individuals on combination antiretroviral therapy are ineligible.
- •Individuals with active uncontrolled hepatitis B or C are ineligible as they are at high risk of lethal treatment-related hepatotoxicity after hematopoietic stem cell transplant.
- •Other investigational drugs within 4 weeks prior to enrollment, unless cleared by the Principal Investigator.
- •Pregnant women are excluded from this study.
研究组 & 干预措施
Regulatory T-cell enriched infusion
Experimental
The doses of Regulatory T-cell enriched infusion will be 2x10^6 cells/kg
干预措施: Regulatory T-cell enriched infusion (Biological)
结局指标
主要结局
Survival
时间窗: 1 year after Regulatory T-cell enriched infusion
Number of patients who survive after Regulatory T-cell enriched infusion
Number of Participants with overall response rate.
时间窗: 1 year post-infusion
Obtain ≥75% the overall response rate at 1 year after infusion
Number of Participants with overall response rate.
时间窗: 6 months post-infusion
Obtain ≥65% the overall response rate at 6 months after infusion
次要结局
- Predictors of clinical response(1 year after infusion)
- Disease evaluation through Symptoms of the disease(Screening, weeks 1, 2, 4, 6, 12 and months 6, 9 and 12 months after infusion)
- Immunologic monitoring and in vivo Treg tracking through lymphocyte(1 year after infusion and after infusion)
- Purity of Treg-enriched cell infusion(Before 24 hours to infusion up infusion day)
- Immunologic monitoring and in vivo Treg tracking through immune globulins(1 year after infusion and after infusion)
- Toxicity monitoring of Treg-enriched cells(Weeks 1, 2, 4, 6, 12 and months 6, 9 and 12 after infusion)
- Disease evaluation through measurement of quality of life(Screening, weeks 1, 2, 4, 6, 12 and months 6, 9 and 12 months after infusion)
- Free survival(1 year after infusion.)
- Immunologic monitoring and in vivo Treg tracking through mononuclear cells(1 year after infusion and after infusion)
- Immunosuppressive requirements.(Screening, month1, months 3, 6, and 12 after infusion)
- Immunologic monitoring and in vivo Treg tracking through plasma(1 year after infusion and after infusion)
- Immunologic monitoring and in vivo Treg tracking through Natural Killer cell subsets(1 year after infusion and after infusion)
- Life-threatening infections(Weeks 1, 2, 4, 6, 12 and months 6, 9 and 12 after infusion)
研究者
研究点 (1)
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