NCT06793956招募中1 期
Open-Label, Phase Ib Study of Sintilimab and Linperlisib Combination Treatment in Patients with Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma (NKTCL)
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年2月21日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- DLT
研究概览
简要总结
This is an open-label, phase Ib study evaluating the combination treatment of sintilimab and linperlisib in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (NKTCL).
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
- •Pathologically confirmed extranodal NKTCL.
- •Voluntary participation in the clinical study; fully understand the study, and have signed the written informed consent form.
- •Age ≥ 18 years.
- •Relapsed or refractory NKTCL after failure of at least one line of asparaginase-based chemotherapy or chemoradiotherapy regimen.
- •ECOG performance status: 0-
- •Estimated survival time ≥ 3 months.
- •At least one measurable lesion according to the Lugano 2014 lymphoma evaluation criteria.
- •Adequate organ and bone marrow function.
排除标准
- •Patients previously treated with PI3K inhibitors.
- •Patients with hemophagocytic syndrome.
- •Patients known to be allergic to any component of monoclonal antibodies.
- •Patients with a history of other malignancies within the past 5 years or concurrent malignancies (excluding basal cell carcinoma of the skin).
- •Patients with aggressive NK-cell leukemia or central nervous system involvement.
- •Patients who have participated in other drug clinical trials within 4 weeks prior to the start of this study or have received anti-tumor treatment within 4 weeks before the study initiation.
- •Patients with clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction) or patients who have undergone total gastrectomy.
- •Patients with a history of interstitial lung disease (except for asymptomatic interstitial lung disease caused by radiotherapy).
研究组 & 干预措施
Sintilimab and Linperlisib Combination Treatment
Experimental
干预措施: Sintilimab and Linperlisib Combination Treatment (Drug)
结局指标
主要结局
DLT
时间窗: Cycle 1 (21 days)
Dose-limiting toxicity
RP2D
时间窗: Cycle 1 (21 days)
Phase II Recommended Dose
次要结局
- Objective response rate (ORR)(Up to 24 weeks)
- AE and SAE(Up to 24 weeks)
- 2-year Progression-free survival(PFS)(Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment)
- 2-year Overall survival(OS)(Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment)
研究者
Qingqing Cai
Professor
Sun Yat-sen University
研究点 (1)
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