NCT06619561招募中2 期
A Phase 2, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, PK, and Efficacy of Vimseltinib in Adults With Active Chronic GVHD After Failure of Prior Systemic Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 26
- 主要终点
- Number of Participants with Dose-Limiting Toxicities (DLTs)
研究概览
简要总结
The purpose of this study is to determine if vimseltinib is safe, tolerable and works effectively to treat adults with active moderate to severe cGVHD. Participants will be treated with vimseltinib in 28-day treatment cycles for approximately 2 years.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be allogeneic hematopoietic stem cell transplant (HSCT) recipients with moderate to severe cGVHD requiring systemic immune suppression.
- •a. May have persistent active acute GVHD (aGVHD) and chronic GVHD (cGVHD) manifestations (overlap syndrome).
- •Participants with active cGVHD who have received and failed at least 2 prior lines of systemic therapy.
- •Stable dose of systemic corticosteroids is permitted but not required. If being taken, participants should be on a stable dose of corticosteroids for at least 2 weeks prior to starting study drug treatment.
- •Adequate organ and bone marrow functions.
- •Participants of reproductive potential agree to follow the contraception requirements.
- •Karnofsky Performance Scale (KPS) of ≥60.
排除标准
- •Has aGVHD without manifestations of cGVHD.
- •Prior use of colony-stimulating factor 1 receptor (CSF1R) inhibitor for cGVHD.
- •History or other evidence of severe illness, uncontrolled infection, or any other conditions that would make the participant unsuitable for the study. All wounds must be healed and free of infection or dehiscence.
- •History of malignancy except for:
- •Underlying malignancy for which the transplant was performed
- •Malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to enrollment and felt to be at low risk for recurrence.
- •Malabsorption syndrome or other illness that could affect oral absorption.
研究组 & 干预措施
Vimseltinib
Experimental
Escalating doses of vimseltinib in 28 day cycles.
干预措施: Vimseltinib (Drug)
结局指标
主要结局
Number of Participants with Dose-Limiting Toxicities (DLTs)
时间窗: Cycle 1 (28 Days)
DLTs assessed for each dose level.
Number of Participants with Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs)
时间窗: Baseline to Study Completion (Estimated up to 24 months)
AEs and SAEs assessed for each dose level.
次要结局
- Objective Response Rate (ORR)(Baseline up to Cycle 7 Day 1 (Cycle = 28 days))
- Duration of Response (DOR)(First CR or PR until PD or Death due to Any Cause (Estimated up to 24 months))
- Failure-Free Survival (FFS)(Baseline to, whichever occurs first of, PD, Addition of Systemic Immune Suppressive Therapy, or Death due to Any Cause (Estimated up to 24 months))
- Organ-Specific Response(Baseline up to Cycle 7 Day 1 (Cycle = 28 days))
- Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax)(Estimated up to 24 months)
研究者
研究点 (26)
Loading locations...
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