Indolent lymphoma
Conditions
Interventions
Experimental group:FKC876 treatment
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed B-cell iNHL. Histological subtypes of B-cell iNHL are limited to follicular lymphoma (FL) grade 1, 2, or 3a, or lymph node marginal zone lymphoma (MZL), or extranodal MZL, according to the WHO classification criteria 2016. 2. Subjects had recurrent or refractory iNHL after previous second-line or above treatment. Prior treatment must include: anti-CD20 monoclonal antibody therapy in combination with an alkylating agent (anti-CD20 monoclonal antibody monotherapy is not a standard line of treatment). Subjects with stable disease (no recurrence) for more than 1 year after completion of the last treatment did not meet the inclusion criteria. 3. At least 1 measurable lesion according to the Lugano 2014 classification (Cheson 2014). Lesions that have previously received radiotherapy are considered measurable only when definite progress is demonstrated after completion of radiotherapy. 4. There is no known history of lymphoma involving the central nervous system (CNS) or suspected history of lymphoma involving the CNS. 5. At least 2 weeks or 5 half-lives (whichever is shorter) from the start of prior systemic therapy, excluding immune checkpoint inhibitors/agonists; Systemic immune checkpoint inhibitors/agonists are treated at least 3 half-lives from leukocytoxism (e.g., Ipilimumab, Ivolumab, Pembrolizumab, Atezolizumab, OX40 agonists, and 4-IBB agonists). 6. Toxic reactions from previous anti-lymphoma therapy must be stable and return to = 18 years. 8. ECOG Physical status score is 0 or 1. 9. Neutrophil absolute value (ANC) >=1.0x10^9/L. 10. Platelet count >=75x10^9/L. 11. Absolute lymphocyte count >=0.1x10^9/L. 12. Adequate kidney, liver, lung and heart function, defined as: (1) Creatinine clearance (estimated by Cockcroft-Gault formula) >= 60 mL/min; (2) Serum ALT/AST = 50%, echocardiography confirmed centerless effusion, no clinically significant arrhythmia; (5) No clinically significant pleural effusion; (6) Baseline percutaneous oxygen saturation under indoor ventilation > 92%. 13. The serum pregnancy test results of fertile women must be negative (women who have undergone surgical sterilization or have been menopausal for at least two years are considered infertile).
Exclusion criteria
Exclusion criteria: 1. Transformed FL and MZL. 2. Small lymphocytic lymphoma. 3. Lymphoplasmacytic lymphoma. 4. Subjects have had other malignancies unless they have been disease-free and have not received antitumor therapy for at least 3 years; Non-melanoma skin tumors, cancers in situ (e.g. cervix, bladder, breast) are excluded. 5. Autologous hematopoietic stem cell transplantation is planned within 6 weeks prior to FKC876 infusion. 6. Allogeneic hematopoietic stem cell transplantation. 7. Have received CD19 targeted therapy. 8. Have received chimeric antigen receptor cell therapy or other genetically modified T cell therapy. 9. History of severe rapid hypersensitivity to aminoglycosides. 10. There is or is suspected to be an uncontrolled fungal, bacterial, viral or other infection that requires intravenous treatment. 11. 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 serological or genetic testing according to the latest version of clinical guidelines/institutional practice to confirm recovery of infection. 12. There is a known history of lymphoma involving the entire gastric wall. 13. Presence of any indwelling tubes or catheters (e.g., percutaneous nephrostomy catheter, indwelling catheter, indwelling biliary drainage tube, or pleural/peritoneal/pericardial catheter). Dedicated central venous access catheters, such as Port-a-Cath or Hickman catheters, are permitted. 14. Lymphoma cells detected in cerebrospinal fluid, or with brain metastases, or a past history of lymphoma cells detected in cerebrospinal fluid or brain metastases. 15. Subjects with lymphoma infiltration in the atrium or ventricle. 16. A history of myocardial infarction, angioplasty or stenting, unstable angina, congestive heart failure classified by the New York Heart Society as grade II or worse, or other clinically significant heart disease in the 12 months prior to enrollment. 17. Emergency treatment is expected to occur within 6 weeks after apheresis due to rapid tumor progression (e.g., tumor mass compression, tumor lysis syndrome). 18. An autoimmune disease (e.g. Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that has resulted in end-organ damage or the need for systemic immunosuppression or other systemic disease control drugs within the past 2 years. Subjects with a history of autoimmune hypothyroidism, patients with type 1 diabetes treated with a stable dose of thyroid replacement hormone therapy, and patients with a stable insulin regimen were eligible for enrollment in this study. 19. A history of symptomatic deep vein thrombosis (DVT) or pulmonary embolism within 6 months prior to enrollment. There was a history of DVT in the upper extremity within 3 months prior to preconditioning chemotherapy. 20. Any medical condition that may affect the assessment of safety or efficacy. 21. Had severe rapid-onset hypersensitivity to any of the drugs to be used in this study. 22. Subjects who received live, attenuated vaccine within 6 weeks or less before the initiation of the preconditioning regimen, or who expected to require the use of such vaccine during the course of the study. 23. Subjects of childbearing age who are breastfeeding. 24. Subjects who do not wish to use contraception from the date of signing informed consent to 6 months after completion of preconditioning chemotherapy or 6 months after completion of F
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Optimal objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response;Partial response;Duration of remission;Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactWu Depei
Outcome results
None listed