R/ R Follicular lymphoma (FL)
Conditions
Interventions
Experimental group:Axicabtagene Ciloleucel Injection
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed follicular lymphoma (FL) grade 1, 2, or 3a according to the WHO 2016 classification criteria; 2. Subjects have relapsed or refractory FL after receiving two or more lines of therapy in the past. Prior therapy must have included: treatment with an anti-CD20 monoclonal antibody in combination with an alkylating agent (anti-CD20 monoclonal antibody monotherapy cannot be used as a standard number of lines of therapy). Subjects whose disease has been stable (without relapse) for more than 1 year after completion of the last treatment do not meet the enrollment criteria; 3. At least 1 measurable lesion according to the Lugano 2014 classification (Cheson 2014). Lesions that have received prior radiotherapy are considered measurable only if they have been confirmed to have definite progression after completion of radiotherapy; 4. Patients with FL lymphoma with secondary central disease may be included; 5. Prior systemic therapy for at least 2 weeks or 5 half-lives (whichever is shorter) from initiation of leukapheresis, with the exception of immune checkpoint inhibitors/agonists; Systemic immune checkpoint inhibitors/agonists have at least 3 half-lives from leukapheresis (eg, Ipilimumab, Ivolumab, Pembrolizumab, Atezolizumab, OX40 agonists, 4-IBB agonists); 6. Toxicities caused by prior anti-lymphoma therapy must be stable and recover to Grade =1 (except for non-clinically significant toxicities, such as alopecia/baldness, etc.); 7.>=18 years; 8. ECOG performance status score of 0 or 1; 9. Absolute neutrophil value (ANC) > = 1.0×10^9/L; 10. Platelet count >= 75×10^9/L; 11. Absolute lymphocyte count > = 0.1×10^ 9/L; 12. Adequate renal, hepatic, pulmonary, and cardiac function, defined as: 1) total bilirubin (TBIL) =60mL/min, creatinine clearance was estimated based on the cockcroft-Gault formula; 4) cardiac ejection fraction > = 50%, echocardiography (ECHO) confirmed no pericardial effusion, no clinically significant arrhythmia; 5) baseline transcutaneous oxygen saturation under indoor ventilation > 92%; 6) No clinically significant pleural effusion. 13. Female of childbearing potential must have a negative serum pregnancy test result (surgically sterilized or postmenopausal for at least 2 years in females considered not of childbearing potential;
Exclusion criteria
Exclusion criteria: 1.Converted FL; 2.Small lymphocytic lymphoma; 3.The histologic grading of FL was 3b; 4.lymphoplasmacytic lymphoma; 5.Subject has had other malignant tumors unless he/she has survived disease-free and has not received antitumor therapy for at least 3 years; except for non-melanoma skin tumors, carcinoma in situ (e.g., cervix, bladder, breast); 6.Autologous Hematopoietic Stem Cell Transplantation Within 6 Weeks Prior to Scheduled Infusion of Achille's Bromide Injection; 7.Has performed allogeneic hematopoietic stem cell transplants; 8.Previous CD19-targeted therapy; 9.Previous chimeric antigen receptor cell therapy or other genetically modified T-cell therapy. 10.History of severe rapid-onset hypersensitivity reactions to aminoglycosides; 11.Presence or suspicion of uncontrolled fungal, bacterial, viral or other infections that require intravenous drug therapy; 12.Known human immunodeficiency virus (HIV) infection or active acute or chronic hepatitis infection (HBV or HCV). Subjects with a history of hepatitis must undergo standard serologic or genetic testing in accordance with the most recent version of clinical guidelines/institutional protocols to confirm resolution of infection prior to enrollment. 13.Known history of lymphoma involving the entire gastric wall; 14.Presence of any indwelling tube or catheter (e.g., percutaneous nephrostomy tube, indwelling urinary catheter, indwelling biliary drain, or pleural/peritoneal/pericardial catheter). Dedicated central venous access catheters such as Port-a-Cath or Hickman catheters are permitted. 15.Patients with primary central nervous system lymphoma (PCNSL); 16.Subjects with lymphomatous infiltration of the atria or ventricles; 17.Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, congestive heart failure class II or worse according to the New York Heart Association cardiac classification, or other clinically significant cardiac disease within 12 months prior to enrollment; 18.Anticipated emergencies requiring urgent treatment due to rapid tumor progression within 6 weeks of leukapheresis (e.g., tumor mass compression, tumor lysis syndrome); 19.End-organ damage due to autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) within the past 2 years, or systemic use of immunosuppressive or other systemic disease-control medications. Subjects with a history of autoimmune hypothyroidism who are on a stable dose of thyroid replacement hormone therapy and type I diabetes mellitus on a stable insulin regimen are eligible for enrollment in this study. 20.History of symptomatic deep vein thrombosis (DVT) or pulmonary embolism within 6 months prior to enrollment and history of DVT at the end of the upper extremity within 3 months prior to pretreatment chemotherapy; 21.Any medical condition that may affect the assessment of safety or efficacy; 22.Has had a severe rapid-onset hypersensitivity reaction to any of the drugs to be used in this study; 23.Live, attenuated vaccines administered within =6 weeks prior to the start of the pretreatment regimen or whose use is expected to be required during the course of the study; 24.Women of childbearing age who are breastfeeding; 25.Male or female subjects who are unwilling to use contraception from the date of signed informed consent until 6 months after completion of pretreatment chemotherapy, or 6 months after completion of an infusion of Aquilensa; 26.Male or fem
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best objective remission rate (bORR);Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete remission (CR) rate;Duration of remission (DOR);Overall survival (OS); | — |
Countries
China
Contacts
Public ContactBing Xu
The First Affiliated Hospital of Xiamen University
Outcome results
None listed