癌研連線CancerLink
已完成 NCT05653271

ACE1831 用於復發性／難治性 CD20 表達 B 細胞惡性腫瘤成人受試者

淋巴瘤Phase I

ACE1831 是一種現成可用的同種異體伽瑪德爾塔 T（gdT）細胞治療，源自健康捐贈者，目前正在研究用於治療 CD20 表達 B 細胞惡性腫瘤。 ACE1831-001 研究是一項開放標籤、第一期、首次人體（FIH）研究，旨在評估 ACE1831 在 CD20 表達非何傑金氏淋巴瘤患者中的安全性與耐受性、藥物動力學與藥效學，以及療效。

適應症：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

收案條件

納入條件

  • 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

排除條件

  • 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

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。