Mantle cell lymphoma
Conditions
Interventions
Experimental group:FKC889 treatment
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed MCL, with cyclin D1 overexpression or chromosome t (11;14) recorded. 2. Have received up to 5 previous MCL treatment regimens. Prior treatment must include chemotherapy containing anthracyclines or bendamustine, as well as anti-CD20 monoclonal antibody therapy, and BTKi therapy such as ibrutinib, zebutinib, or obutinib. 3. Recurrent or refractory disease, defined as disease progression after the last treatment, or refractory disease, defined as failure to achieve partial response (PR) or CR after the last treatment. 4. Have at least one measurable lesion. Lesions that have previously received radiotherapy are considered measurable only when definite progress is demonstrated after completion of radiotherapy. If only lymph nodes are measurable, at least one node should be >=2 cm. 5. Magnetic resonance imaging (MRI) showed no evidence of central nervous system (CNS) lymphoma. 6. In addition to systemic immune checkpoint inhibitor/stimulant therapy, at least 2 weeks or 5 half-lives (whichever is shorter) separated prior systemic therapy or BTKi therapy (ibutinib, Zebutinib or Aubutinib, etc.; If applicable) from the subject's scheduled date of leucocytomy. At least 3 half-lives (e.g., ipilimumab, nabuliumab, parbolizumab, attilizumab, OX40 agonist, 4-1BB agonist) separated prior treatment with systemic immune checkpoint inhibitors/stimulants from the subject's scheduled date of leucocytometry. 7. Toxicity from previous treatment must be stable and return to = 18 years. 9. The Eastern Oncology Collaboration (ECOG) physical status score was 0 or 1. 10. Absolute neutrophil count (ANC) >=1.0x10^9/L. 11. Platelet count >=75x10^9/L. 12. Lymphocyte absolute value count >=0.1x10^9/L. 13. Adequate kidney, liver, lung, and heart function, defined as creatinine clearance (estimated by the Cockcroft-Gault formula) >=60 cc/min; Serum alanine aminotransferase/aspartate aminotransferase =50%, echocardiography (ECHO) confirmed centerless effusion, no clinically significant arrhythmia; No clinically significant pleural effusion; Baseline percutaneous oxygen saturation under indoor ventilation > 92%. 14. The serum pregnancy test results of fertile women must be negative (women who have been surgically sterilized or who have been postmenopausal for at least two years are considered infertile).
Exclusion criteria
Exclusion criteria: 1. Subjects have had other malignancies unless they have survived disease free and have not received antitumor therapy for at least 3 years; Non-melanoma skin tumors, carcinoma in situ (e.g. cervix, bladder, breast) are excluded; 2. Autologous hematopoietic stem cell transplantation was performed within 6 weeks prior to the planned FKC889 infusion; 3. Allogeneic hematopoietic stem cell transplantation; 4. Have received CD19 targeted therapy; 5. Have received chimeric antigen receptor cell therapy or other genetically modified T cell therapy; 6. History of severe rapid hypersensitivity to aminoglycosides; 7. There is or is suspected to be an uncontrolled fungal, bacterial, viral or other infection that requires intravenous treatment. Simple urinary tract infection (UTI) and simple bacterial pharyngitis are allowed if they respond to aggressive treatment and after consultation with the Fosun Kate medical examiner; 8. A history of human immunodeficiency virus (HIV) infection, treponema pallidum infection, or acute or chronic active hepatitis B or C infection. Patients with a history of hepatitis infection must be determined to have cleared the infection based on standard serological and genetic testing; 9. Presence of any indwelling tubes or catheters (e.g., percutaneous nephrostomy catheter, indwelling biliary drainage tube, indwelling catheter, or pleural/peritoneal/pericardial catheter). The presence of dedicated central venous access catheters such as Port-a-Cath or Hickman catheters is permitted; 10. A history of myocardial infarction, cardiac angioplasty or stenting, unstable angina, active arrhythmia, or other clinically significant heart disease within 12 months prior to enrollment; 11. Lymphoma cells detected in cerebrospinal fluid, or brain metastases, or a past history of central nervous system (CNS) lymphoma, cerebrospinal fluid lymphoma cells, or brain metastases; 12. Existing or prior CNS disease, such as seizures, cerebral ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, reversible posterior encephalopathy syndrome, or any autoimmune disease with CNS involvement; 13. Subjects with lymphoma infiltration in the atrium or ventricle; 14. There was a history of deep vein thrombosis or pulmonary embolism requiring anticoagulant therapy within 6 months prior to enrollment; 15. It is estimated that within 6 weeks after leukocytic apheresis, an emergency may occur due to rapid tumor progression and require emergency treatment (e.g., tumor mass effect, tumor lysis syndrome); 16. Primary immunodeficiency; 17. Any medical condition that may affect the assessment of safety or efficacy; 18. Had severe rapid-onset hypersensitivity to any of the drugs to be used in this study; 19. Administer live vaccine within 6 weeks before starting the pretreatment programme; 20. Lactating subjects; 21. Subjects who are unwilling to use contraception from the time of signing informed consent to the completion of FKC889 infusion within 6 months; 22. Subjects judged by the investigator had difficulty in completing all visits or operations required by the study protocol (including follow-up visits), or were not compliant enough to participate in the study; 23. An autoimmune disease (e.g. Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that has caused end-organ damage within the last 2 years or that requires systemic use of immunosuppressive or other systemic disease control drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Optimal objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response;Partial response;Objective response rate;Duration of remission;Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactZhu Jun
Beijing Cancer Hospital
Outcome results
None listed