本研究的目的是在復發/難治性非霍奇金淋巴瘤參與者中評估BMS-986458作為單一藥物和與抗淋巴瘤藥物聯合使用的安全性、耐受性、藥物水平以及初步生物和臨床活性。BMS-986458是一種B細胞淋巴瘤6 (BCL6)的雙功能大腦素依賴性配體定向降解劑。
適應症：Relapsed/Refractory Non-Hodgkin Lymphoma
收案條件
納入條件
- 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.
排除條件
- 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.
收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。