A Phase I/II Clinical Study to Evaluate the Efficacy and Safety of GW5282 in Combination With Golidocitinib in the Treatment of T-Cell Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 165
- 试验地点
- 12
- 主要终点
- Part A: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
研究概览
简要总结
This is a phase 1/2 open-label study to evaluate GW5282 in combination with golidocitinib (G2 regimen) for the treatment of T-cell lymphoma. In the first phase of the study, the maximum tolerated dose will be determined through dose escalation; in the second phase, the potential therapeutic advantages of the novel combination therapy over the conventional CHOP regimen will be preliminarily assessed through a randomized controlled design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Signed informed consent;
- •Adult ≥ 18 years of age;
- •ECOG performance status score ≤ 2;
- •Life expectancy of not less than 12 weeks;
- •Histopathologically confirmed diagnosis of PTCL;
- •Presence of measurable disease;
- •Adequate bone marrow function and vital organ function reserve;
- •Ability to comply with study requirements and to complete study-related procedures;
- •Adequate contraception during participation in the trial.
排除标准
- •Presence of unresolved drug-related adverse events greater than Grade 1;
- •Lymphoma involving the central nervous system;
- •Failure to complete the required washout period for other anti-tumor therapies;
- •Corticosteroid use that does not meet protocol requirements;
- •Major surgery/trauma within a short period, or planned major surgery within a short period;
- •Vaccination with a live vaccine within a short period;
- •Inability to discontinue prohibited medications;
- •Requirement for immunosuppressive agents or biologics due to an underlying disease;
- •Presence of active infection;
- •Significant cardiovascular disease;
- •Presence of gastrointestinal disease that might affect drug intake or absorption;
- •History of other malignancies;
- •Known allergy to the study drug;
- •Other severe or uncontrolled systemic diseases;
- •Personnel with a conflict of interest (e.g., site staff, sponsor employees);
- •Pregnant or breastfeeding women;
- •Inability to comply with protocol requirements.
研究组 & 干预措施
Dose escalation cohorts (Part A, non-randomized)
干预措施: GW5282 combined with Golidocitinib (Drug)
Dose expansion cohorts (Part B, randomized)
干预措施: GW5282 combined with Golidocitinib (Drug)
Control cohort (Part B, randomized)
干预措施: Conventional CHOP regimen (Drug)
结局指标
主要结局
Part A: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
时间窗: The DLT observation period is defined as the 21 days after the first dose.
To evaluate the safety and tolerability of the combination of GW5282 and golidocitinib. Dose Limiting Toxicity (DLT) was evaluated in the DLT observation frame.
Part B: Complete Response Rate (CRR) According to Lugano 2014 by Investigators' Review
时间窗: Up to 6 cycles, each cycle is 21 days
To evaluate anti-tumor activity of GW5282 combined with golidocitinib as a chemo-free induction therapy for newly diagnosed PTCL, and compare it with conventional CHOP regimen.
次要结局
- Part A: Plasma concentration of GW5282 and golidocitinib(C1D1, C1D15, and Day 1 of Cycle 2~9)
- Part A: Efficacy parameters(through the study completion, an average of around 1~2 years)
- Part B: Other efficacy parameters(through the study completion, an average of around 1~2 years)
- Part B: Adverse Events (AEs) / Serious Adverse Events (SAEs)(through the study completion, an average of around 1~2 years)
- Part B: Plasma concentration of GW5282 and golidocitinib(C1D1, C1D15, and Day 1 of subsequent cycles till treatment discontinuation)