Safety and Efficacy of Early Second Infusion of Axi-cel Based on ctDNA for R/R Large B - Cell Lymphoma

Korábbi kezelés

• Unstable systemic diseases, including but not limited to:
  • Active infections (excluding localized infections), Unstable angina, Cerebrovascular accident or transient ischemic attack (within 6 months prior to screening), Myocardial infarction (within 6 months prior to screening), Congestive heart failure (NYHA Class ≥III), Severe arrhythmia requiring pharmacologic management, Hepatic, renal, or metabolic disorders.
• Grade ≥3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) following prior axi-cel therapy.

Más betegség

• History of malignancies other than DLBCL, PMBCL, TFL, or HGBCL within 5 years prior to screening, except:
  • Adequately treated carcinoma in situ of the cervix, Basal cell or squamous cell carcinoma of the skin, Localized prostate cancer after definitive resection, Ductal carcinoma in situ of the breast after curative surgery, Thyroid cancer after radical treatment.
• Conditions affecting informed consent or protocol compliance:
  • Physical or psychological disorders impairing the ability to provide written informed consent, Inability or unwillingness to comply with study requirements.
• Active, uncontrolled serious infections.
• Other conditions deemed by the investigator to confer unacceptable risk or render the patient ineligible.

Egyéb

• Uncontrolled active comorbidities that preclude study participation.

• Age ≥18 years, regardless of gender.
• Life expectancy \>12 weeks.
• ECOG performance status 0-2.
• Histologically or cytologically confirmed B-cell non-Hodgkin lymphoma per WHO 2016 classification, including:
  • Diffuse large B-cell lymphoma (DLBCL) Primary mediastinal large B-cell lymphoma (PMBCL) Transformed follicular lymphoma (TFL) High-grade B-cell lymphoma (HGBCL).
• Relapsed/refractory disease, defined as:
  • ≥1 prior relapse, Failure to achieve partial response (PR) after 2-3 cycles of first-line therapy, Failure to achieve complete response (CR) after 4-6 cycles of first-line therapy, Primary refractory disease, Secondary refractory disease, Disease progression following last line of therapy.
• Adequate venous access for leukapheresis, with:
  • Hemoglobin ≥80 g/L, Absolute neutrophil count ≥1.0 ×10⁹/L, Platelet count ≥75 ×10⁹/L, OR parameters not meeting above thresholds but deemed acceptable for mononuclear cell collection per investigator's judgment.
• ≥1 measurable lesion per Lugano 2014 response criteria.
• Organ function requirements:
  • Renal: Serum creatinine ≤2×ULN OR creatinine clearance ≥40 mL/min (Cockcroft-Gault formula).
  • Cardiopulmonary:
  • Left ventricular ejection fraction (LVEF) \>50%, Baseline oxygen saturation \>92% on room air.
  • Hepatic:
  • Total bilirubin ≤2×ULN (≤5×ULN in Gilbert syndrome), ALT/AST ≤3×ULN (≤5×ULN in patients with hepatic involvement).
• Negative serum pregnancy test for women of childbearing potential (WOCBP). Postmenopausal (≥2 years since last menses) or surgically sterilized women are exempt.
• Within 60 days post-axi-cel:
  • Persistent ctDNA(+) or ctDNA(-→+) under CR or PET/CT-confirmed PR