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.
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. A total of 12 adult subjects with r/r LBCL who are refractory to first-line immunochemotherapy or who relapse within 12 months after first-line immunochemotherapy will be enrolled. All subjects will undergo leukapheresis, bridging therapy, conditioning chemotherapy, and a single study drug infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
CD19 CAR-T
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGThe Frist Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Objective response rate (ORR)
Proportion of subjects with a best overall response of complete remission (CR) or partial remission (PR), as assessed by the Lugano 2014 classification (Cheson 2014)
Time frame: Up to 24 months
Complete response rate (CRR)
Proportion of subjects achieving hematologic complete response (CR) according to the NCCN 2023
Time frame: Within 6 months,12 months, and 24 months after FKC876 infusion
Duriation of response (DOR)
The time from the first objective response to disease progression (per Cheson 2014) or death due to any cause, whichever occurs first, in subjects who achieve an objective response.
Time frame: Up to 24 months
Progression-frees survival (PFS)
The time from the date of axicabtagene ciloleucel infusion to disease progression or death due to any cause, whichever occurs first
Time frame: Up to 24 months
Overall survival(OS)
The time from the date of axicabtagene ciloleucel infusion to death due to any cause.
Time frame: Up to 24 months
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Shanghai Jiaotong University School of Medicine Ruijin Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGWest China Hospotal Sichuan University
Chengdu, Sichuan, China
RECRUITINGTianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
RECRUITING