Relapsed/Refractory Large B-cell Lymphoma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGFKC876 injection
CD19 CAR-T
Sponsors
Shenzhen Fosun Kairos Biotechnology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or older at the time of informed consent 2. Has signed the informed consent form (ICF) 3. Histologically proven large B-cell lymphoma 4. Relapsed or refractory disease after first-line chemoimmunotherapy 5. The subject has at least one measurable lesion on imaging 6. No clinical or historical evidence suggestive of lymphoma involvement of the central nervous system (CNS) 7. 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. 8. Toxicities due to prior therapy must be stable or recovered to ≤ Grade 1 9. ECOG performance status of 0 or 1 10. Adequate bone marrow, renal, hepatic, pulmonary and cardiac function 11. 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.
Exclusion criteria
1. Prior history of other malignancies, with the exception of non-melanoma skin tumors, carcinoma in situ , or follicular lymphoma that have been free of recurrence for more than 3 years. 2. History of Richter's transformation of CLL or PMBCL 3. History of autologous or allogeneic stem cell transplant 4. Received more than one line of therapy for DLBCL 5. Treatment with systemic immunostimulatory agents within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to the first dose of axicabtagene ciloleucel 6. Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy 7. History of severe, immediate hypersensitivity reaction attributed to aminoglycosides or Tocilizumab 8. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management 9. Known history of infection with human immunodeficiency virus (HIV) or Positive test result for anti-Treponema pallidum antibody (TP-Ab) or hepatitis B(HBsAg positive) or hepatitis C virus (anti-HCV positive) 10. Active tuberculosis 11. Presence of any indwelling line or drain 12. Subjects with detectable malignant cells in the cerebrospinal fluid (CSF) or known brain metastases or with a history of cerebrospinal fluid malignant cells or brain metastases 13. History or presence of non-malignant CNS disorder 14. Subjects with cardiac atrial or cardiac ventricular lymphoma involvement 15. History of clinically significant cardiac disease within 12 months of enrollment 16. Requirement for urgent therapy within 6 weeks due to tumor mass effects, such as bowel obstruction or blood vessel compression or airway obstruction 17. Patients with idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on chest CT are excluded. 18. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment 19. Women of childbearing potential who are pregnant or breastfeeding 20. In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | Up to 24 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete response rate (CRR) | Within 6 months,12 months, and 24 months after FKC876 infusion | Proportion of subjects achieving hematologic complete response (CR) according to the NCCN 2023 |
| Duriation of response (DOR) | Up to 24 months | 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. |
| Progression-frees survival (PFS) | Up to 24 months | The time from the date of axicabtagene ciloleucel infusion to disease progression or death due to any cause, whichever occurs first |
| Overall survival(OS) | Up to 24 months | The time from the date of axicabtagene ciloleucel infusion to death due to any cause. |
Countries
China
Contacts
CONTACTZhizhong Geng
STUDY_CHAIRWen Shi
FosunKarios
Outcome results
None listed