A Single-arm, Multicenter Clinical Study Evaluating the Efficacy and Safety of Axicabtagene Ciloleucel Injection Manufactured by an Automated Process in Patients With Relapsed/Refractory Large B-cell Lymphoma.
This study is a single-arm, multicenter, open-label clinical study evaluating the efficacy and safety of axicabtagene ciloleucel injection manufactured by an automated cell preparation process in adult subjects with relapsed or refractory large B-cell lymphoma (r/r LBCL) as second-line therapy.
• Age 18 years or older at the time of informed consent
• Has signed the informed consent form (ICF)
• Histologically proven large B-cell lymphoma
• Relapsed or refractory disease after first-line chemoimmunotherapy
• The subject has at least one measurable lesion on imaging
• No clinical or historical evidence suggestive of lymphoma involvement of the central nervous system (CNS)
• A washout period of at least 2 weeks or 5 half-lives (whichever is shorter) from the last prior systemic therapy to the signing of the informed consent form.
• Toxicities due to prior therapy must be stable or recovered to ≤ Grade 1
• ECOG performance status of 0 or 1
⁃ Adequate bone marrow, renal, hepatic, pulmonary and cardiac function
⁃ Female subjects of childbearing potential must have a negative serum pregnancy test . Male and female subjects of childbearing potential must agree to use highly effective contraception during the study and for 6 months post-infusion.