癌研連線CancerLink
已完成 NCT05653271

ACE1831 用于复发性／难治性 CD20 表达 B 细胞恶性肿瘤成人受试者

淋巴瘤Phase I

ACE1831 是一种现成可用的同种异体伽玛德尔塔 T（gdT）细胞治疗，源自健康捐赠者，目前正在研究用于治疗 CD20 表达 B 细胞恶性肿瘤。 ACE1831-001 研究是一项开放标签、第一期、首次人体（FIH）研究，旨在评估 ACE1831 在 CD20 表达非何杰金氏淋巴瘤患者中的安全性与耐受性、药物动力学与药效学，以及疗效。

适应症：B-cell Lymphoma、Non Hodgkin Lymphoma、DLBCL、Primary Mediastinal Large B Cell Lymphoma、Marginal Zone Lymphoma、Follicular Lymphoma、Burkitt Lymphoma、High-grade B-cell Lymphoma

入组条件

纳入标准

  • CD20-positive B-cell NHL that is persistent or progressive after having received at least 2 prior systemic therapies per NCCN guidelines
  • At least 1 measurable lesion according to the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 or subjects with ECOG scores of 2 with a serum albumin of \>3.5
  • Adequate hematologic and renal, hepatic, and cardiac function
  • Oxygen saturation via pulse oxygenation ≥ 92% at rest on room air

排除标准

  • Prior treatment with a genetically modified cell therapy product targeting CD20
  • Autologous stem cell transplant within 6 weeks of informed consent or history of allogeneic stem cell transplantation
  • History of central nervous system (CNS) lymphoma or primary CNS lymphoma
  • History or presence of clinically relevant CNS disorder (e.g. epilepsy)
  • Clinically significant active infection
  • Currently active, clinically significant cardiovascular disease
  • Human Immunodeficiency virus (HIV) infection (however, subjects on anti-retroviral therapy for at least 4 weeks and with HIV viral loads of \<400 copies/mL are eligible), active hepatitis B infection, or hepatitis C infection
  • History of other malignancies with the exception of certain treated malignancies with no evidence of disease
  • Primary immunodeficiency disorder
  • Pregnant or lactating female
  • Any medical, psychological, familial, or sociological conditions that, in the opinion of the Investigator or Sponsor Medical Monitor, would impair the ability of the subject to receive study treatment, comply with study requirements, or understanding of the informed consent

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。