本研究的目的是在复发/难治性非霍奇金淋巴瘤参与者中评估BMS-986458作为单一药物和与抗淋巴瘤药物联合使用的安全性、耐受性、药物水平以及初步生物和临床活性。BMS-986458是一种B细胞淋巴瘤6 (BCL6)的双功能大脑素依赖性配体定向降解剂。
适应症：Relapsed/Refractory Non-Hodgkin Lymphoma
入组条件
纳入标准
- Participants ≥ 18 years of age with frontline or R/R NHL.
- 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).
- Participants must accept and follow pregnancy prevention plan.
排除标准
- Participants must not have an Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.
- Participants with an inability to comply with listed restrictions, precautions and prohibited treatments.
- Participants must not have prior CAR-T, or radiotherapy ≤ 4 weeks, systemic anticancer treatment ≤ 5 half-lives or 4 weeks, allogeneic SCT ≤ 6 months (only applicable to BMS-986458 single agent or rituximab combination cohorts), or autologous SCT ≤ 3 months prior to study intervention initiation.
- In BMS-986458 + T-cell engager combination cohorts: Participants must not have prior alloSCT or solid organ transplantation, history of confirmed progressive multifocal leukoencephalopathy (PML); known or suspected history of hemophagocytic lymphohistiocytosis (HLH); known or suspected chronic active Epstein-Barr (EBV) infection.
- 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.
- Participants must not have known or suspected central nervous system involvement.
入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。