2023-506654-20-00
招募中
1/2 期
A Phase 1/2, multi-center, Open-label, Dose-finding Study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986458, alone and in combination with antilymphoma agents in Subjects with Relapsed/Refractory non-Hodgkin lymphomas (R/R NHL)
Bristol-Myers Squibb Services Unlimited Company20 个研究点 分布在 4 个国家目标入组 166 人开始时间: 2024年2月20日最近更新:
概览
- 阶段
- 1/2 期
- 状态
- 招募中
- 发起方
- Bristol-Myers Squibb Services Unlimited Company
- 入组人数
- 166
- 试验地点
- 20
- 主要终点
- Incidence of adverse events (AEs)
概览
简要总结
1/To assess the safety and tolerability of BMS-986458 as a single agent and in combination with anti-lymphoma agents in participants with R/R NHL 2/To determine the RP2D(s) of BMS-986458 as a single agent and in combination with anti-lymphoma agents in participants with R/R NHL.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Participants ≥ 18 years of age with R/R NHL (including DLBCL [ie, DLBCL not otherwise specified (NOS) and diffuse large B-Cell lymphoma/high-grade B-Cell lymphoma with MYC and BCL2 rearrangements], and FL):
- •For R/R DLBCL (de novo) and FL 3b: following at least 2 prior lines of therapy (eg, first-line combination chemotherapy regimen containing rituximab, anthracycline, an alkylating agent, and steroids and at least one additional treatment).
- •For R/R DLBCL (transformed lymphoma): following at least 2 prior lines of therapy which must have been administered after transformation.
- •For R/R FL (except for FL 3b): following at least 2 prior lines of therapy and meeting treatment criteria at the time of enrollment based on investigator´s assessment.
- •Participant must have measurable disease (defined by at least one FDG-avid lesion for FDG-avid disease and one bi-dimensionally measurable disease on cross sectional imaging by computed tomography or magnetic resonance imaging with at least one lesion > 1.5 cm in the transverse diameter) and must accept and follow pregnancy prevention plan.
排除标准
- •Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2
- •Inability to comply with listed restrictions, precautions and prohibited treatments
- •Prior CAR-T, Cereblon-modulating drug or radiotherapy ≤ 4 weeks, systemic anticancer treatment ≤ 5 half-lives or 4 weeks, allogeneic SCT ≤ 6 months or autologous SCT ≤ 3 months prior to study intervention initiation
- •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; known or suspected central nervous system involvement.
结局指标
主要结局
Incidence of adverse events (AEs)
Incidence of adverse events (AEs)
Serious adverse events (SAEs)
Serious adverse events (SAEs)
AEs meeting protocol defined dose limiting toxicity (DLT) criteria
AEs meeting protocol defined dose limiting toxicity (DLT) criteria
AEs leading to discontinuation, and death
AEs leading to discontinuation, and death
次要结局
- Summary measures of BMS-986458 PK parameters
- Overall response rate, Duration of response, Time to response, Progression free survival, Overall Survival
研究者
GSM-CT
Scientific
Bristol-Myers Squibb Services Unlimited Company
研究点 (20)
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