癌研連線CancerLink
招募中 NCT06526793

Surovatamig (AZD0486)作為復發/難治性(R/R) B細胞NHL參與者的單一療法

淋巴瘤白血病Phase II

這是一項2期全球、多中心、開放標籤的研究，評估蘇羅瓦他米(AZD0486)單藥治療在既往接受過至少兩線治療的復發/難治性B細胞非霍奇金淋巴瘤(NHL)成人參與者中的有效性、安全性和耐受性。本研究有2個單元： FL單元1和LBCL單元2。

適應症：B-cell Non-Hodgkin Lymphoma、Follicular Lymphoma (FL)、Large B-Cell Lymphoma (LBCL)

收案條件

納入條件

  • Aged 18 years old and above
  • Histologically confirmed relapsed refractory FL (Module 1) and LBCL (Module 2) after at least 2 prior lines of therapy
  • ECOG performance status 0 to 2
  • Locally confirmed CD-19 expression in lymphoma cells after progression from last CD 19 directed therapy
  • FDG-avid disease with at least one bi-dimensionally measurable nodal lesion (defined as \> 1.5 cm in its longest dimension), or extranodal lesion (defined as \> 1.0 cm in its longest dimension)
  • Adequate hematological function: ANC ≥ 1000/mm3, platelets
  • ,000/mm3, hemoglobin ≥ 9 g/dL. Transfusion and/or growth factor are allowed but counts must be stable for at least 72 hours afterwards prior to screening
  • Adequate liver function: total bilirubin \<1.5x ULN, AST/ALT ≤ 3xULN or \< 5 × ULN in the presence of lymphoma involvement of the liver
  • Adequate renal function: creatinine clearance (CrCl) of ≥ 45 mL/min
  • Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 45% by echocardiogram or MUGA

排除條件

  • Diagnosis of CLL, Burkitt lymphoma, or Richter's transformation
  • Active CNS involvement by B-NHL
  • Leukemic presentation of B-NHL
  • History of a clinically relevant CNS medical condition or pathology that required treatment in the preceding year, is currently symptomatic, or that the treating investigator considers to have the potential to interfere with the evaluation of safety, such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, neurodegenerative disorder including Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis or other severe mental illness.
  • Prior therapy with T-cell engager (TCE) within 8 weeks, autologous Hematopoietic Stem Cell Transplantation (HSCT) within 12 weeks, CAR T- cell therapy within 6 months, or prior allogeneic HSCT within 24 weeks of first dose of surovatamig
  • Requires chronic immunosuppressive therapy
  • Unresolved non hematological AEs ≥ Grade 2 from prior therapies; history of ≥ Grade 3 CRS or neurotoxicity from prior CAR-T or TCE therapy
  • History of major cardiac abnormalities.
  • If female, participant must not be pregnant or breastfeeding.

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。