NCT06733441进行中（未招募）1 期
Phase 1b, Randomized, Dose Optimization Study to Assess the Anti-Tumor Activity, Safety, and Pharmacokinetics of TLN-254 in Patients With Relapsed or Refractory T-cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- Percentage of Participants With Objective Response
研究概览
简要总结
The primary purpose of this study is to evaluate the anti-tumor activity of TLN-254 monotherapy in participants with relapsed or refractory T-cell lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •At least 18 years of age at the time of signing the informed consent form (ICF).
- •Type of Participant and Disease Characteristics:
- •Cohort 1: Peripheral T-cell lymphoma (PTCL) that has relapsed after, or not responded to at least one prior systemic treatment regimen. Participants with Anaplastic large cell lymphoma (ALCL) should have received prior brentuximab vedotin treatment.
- •Nodal T-follicular helper (TFH) cell lymphoma angioimmunoblastic; Follicular helper T-cell lymphoma, angioimmunoblastic type (angioimmunoblastic T-cell lymphoma).
- •Nodal TFH cell lymphoma, follicular type; Follicular helper T-cell lymphoma, follicular type.
- •Nodal TFH cell lymphoma, not otherwise specified (NOS); Follicular helper T-cell lymphoma, NOS.
- •PTCL, NOS.
- •Anaplastic large-cell lymphoma, Alkaline phosphatase (ALK) positive.
- •Anaplastic large-cell lymphoma, ALK negative.
- •Cohort 2: Relapsed/refractory CTCL which has relapsed after, or not responded to at least two prior systemic treatments.
- •Sezary syndrome
- •Mycosis fungoides
- •Participant must have measurable disease at study entry.
- •Freshly biopsied or archival tissue available.
- •Diagnostic Assessments:
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or
- •Adequate organ function.
- •Contraception:
- •Participants must accept and follow the pregnancy prevention plan.
排除标准
- •Medical Conditions:
- •Participants must not have prior systemic anti-cancer treatment less than or equal to (≤) 5 half-lives or 4 weeks, allogeneic SCT≤90 days or autologous SCT ≤60 days prior to study intervention initiation.
- •Participants must not have any condition, including significant acute or chronic medical illness, active or uncontrolled infection, or the presence of laboratory abnormalities, that places participants at unacceptable risk if participating in this study.
- •Current or past history of central nervous system (CNS) involvement.
- •Other Exclusions:
- •Pregnant or lactating women.
- •Unable to swallow tablets.
研究组 & 干预措施
Cohort 1: TLN-254 Single Agent
Experimental
干预措施: TLN-254 (Drug)
Cohort 2: TLN-254 Single Agent
Experimental
干预措施: TLN-254 (Drug)
结局指标
主要结局
Percentage of Participants With Objective Response
时间窗: Up to 2 years
Percentage of Participants With CR
时间窗: Up to 2 years
Percentage of Participants With PR
时间窗: Up to 2 years
次要结局
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Up to 2 years)
- Number of Participants With Severity of TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0(Up to 2 years)
- Plasma concentrations of TLN-254(Day 1 of Cycle 1 and Day 1 of each even numbered Cycle for up to 2 years (Each Cycle length =28 days))
- Duration of Response (DOR)(Up to 2 years)
研究者
研究点 (10)
Loading locations...
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