Study to Evaluate the Efficacy and Safety of Relmacabtagene Autoleucel (Relma-cel) as First-Line Therapy in Adult Participants With High-Risk Large B-Cell Lymphoma
The primary objective of this study is to estimate the efficacy of Relmacabtagene Autoleucel in participants with high-risk large B-cell lymphoma.
• ≥ 18 years old;
• Sign on the informed consent;
• Histologically confirmed large B-cell lymphoma that also meets the definition of high-risk large B-cell lymphoma as a lymphoma International Prognostic Index (IPI) score of 3-5 and/or high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement (double/triple-hit lymphoma) (DHL/THL) and must be treated with 2 cycles of CD20 monoclonal antibodies combined with anthracyclines. Presence of positive PET assessable lesions (DS score of 4 or 5) as determined by the Lugano criteria (Cheson et al., 2014);
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Expected survival greater than 12 weeks;
• Adequate organ function:
‣ Absolute neutrophil count ≥ 1000/μL;Absolute lymphocyte count ≥ 100/μL; Platelet count ≥ 75,000/μL;Hb ≥ 80g/L;
⁃ Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (Cockcroft-Gault formula) \> 50 mL/min (serum creatinine clearance due to lymphoma mass compression should be \> 30 mL/min);
⁃ Serum alanine aminotransferase (ALT) ≤ 5 upper limit of normal (ULN) and total bilirubin ≤2ULN(or for subjects with Gilbert's syndrome or lymphoma invading the liver \< 3 ULN);
⁃ Baseline oxygen saturation \> 92% on room air;
⁃ Left ventricular ejection fraction (LVEF) ≥50% assessed by echocardiography or radionuclide activity angiography (MUGA) within 1 month of enrollment;
• Adequate vascular access for leukapheresis procedure;
• Women of childbearing potential must agree to use highly effective methods of contraception for at least 28 days prior to lymphocyte clearance chemotherapy through 1 year after Relmacabtagene Autoleucel infusion; Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after Relmacabtagene Autoleucel infusion.