NCT07082803招募中1 期
An Open-Label, Multicenter, Phase 1 Trial to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of TLN-121 as a Single Agent and in Combination With Other Anti-Lymphoma Agents, in Patients With Relapsed or Refractory Non-Hodgkin Lymphomas
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 21
- 主要终点
- Number of participants experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-121 alone or in combination with TLN-254.
研究概览
简要总结
The primary purpose of this study is to evaluate the safety, pharmacokinetics,, and preliminary anti-tumor activity of TLN-121 as a single agent and in combination with other anti-lymphoma therapies in patients with relapsed or refractory Non-Hodgkin Lymphomas
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Disease Characteristics
- •Participant must have measurable disease at study entry
- •Participants must have one of the following histologically documented hematologic malignancies:
- •Large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBLC), not otherwise specified (DLBCL, NOS), Follicular lymphoma (FL) grade 3b, transformed lymphoma from FL, or High-Grade B-Cell lymphoma (HGBCL) following at least 2 prior lines of therapy.
- •FL grade 1-3a that requires treatment following at least 2 prior lines of therapy.
- •The following Peripheral T-cell lymphoma (PTCL) subtypes that have relapsed after, or not responded to at least 1 prior systemic treatment regimen:
- •Nodal T-follicular helper (Tfh) cell lymphoma angioimmunoblastic; Follicular helper T-cell lymphoma, angioimmunoblastic type (AITL).
- •Nodal Tfh cell lymphoma, follicular type; Follicular helper T-cell lymphoma, follicular type.
- •Nodal Tfh cell lymphoma, NOS; Follicular helper T-cell lymphoma, NOS.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
排除标准
- •Participants must not have current central nervous system (CNS) involvement. Participants with past history of CNS involvement of lymphoma must have had CNS disease fully treated with no evidence of recurrence within 12 months.
- •Participant must not have a history of autologous stem cell transplantation within 60 days or allogeneic stem cell transplantation within 90 days prior to the start of the study.
- •Participant must not have a history of CAR T-cell or other T-cell targeting treatment ≤ 4 weeks prior to the start of the study.
- •Participant must not have major surgery or severe trauma within 4 weeks prior to the start of the study.
- •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.
- •Pregnant or lactating.
- •Conditions that could affect drug absorption.
研究组 & 干预措施
Single Agent
Experimental
干预措施: TLN-121 (Drug)
Combination Treatment
Experimental
干预措施: TLN-121 (Drug)
Combination Treatment
Experimental
干预措施: zeprumetostat (TLN-254) (Drug)
结局指标
主要结局
Number of participants experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-121 alone or in combination with TLN-254.
时间窗: Up to 2 years
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs)
时间窗: Up to 2 years
Clinically significant ECG QT Interval from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0
时间窗: Up to 2 years
Clinically significant laboratory abnormalities from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0
时间窗: Up to 2 years
次要结局
- Area Under the Plasma Concentration-Time Curve (AUC) of TLN-121(Up to 2 years)
- Anti-tumor activity of TLN-121 and TLN-121 in combination with TLN-254 by evaluating the objective response rate (ORR) according to the Lugano response criteria for Non-Hodgkin Lymphoma(Up to 2 years)
- Maximum Observed Plasma Concentration (Cmax) of TLN-121(Up to 2 years)
- Time to Maximum Plasma Concentration (Tmax) of TLN-121(Up to 2 years)
- Minimum Observed Plasma Concentration (Cmin) of TLN-121(Up to 2 years)
- Anti-tumor activity of TLN-121 and TLN-121 in combination with TLN-254 by evaluating the duration of response (DOR) as assessed by the time from the date of first objective response to the date of disease progression(Up to 2 years)
- Anti-tumor activity of TLN-121 and TLN-121 in combination with TLN-254 by evaluating the complete response rate (CR) according to the Lugano response criteria for Non-Hodgkin Lymphoma(Up to 2 years.)
研究者
研究点 (21)
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