Relapsed/refractory B-cell non-Hodgkin's lymphoma
Conditions
Interventions
6 groups:Continuous intravenous infusion, 24 hours uninterrupted infusion, continuous intravenous infusion for 4 weeks
Sponsors
Peking Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Sign the informed consent form voluntarily, sign and indicate the date; 2.Male or female, aged 18 to 75 years old; 3.Types of patients (World Health Organization classification) confirmed histopathologically, including: (1) Follicular lymphoma (grade I-III) (FL); (2) Marginal zone lymphoma (MZBL); (3) Lymphomaplasma cell lymphoma (LPL); (4)Mantle cell lymphoma (MCL); (5)Small lymphocytic lymphoma (SLL); (6)Transforming large B-cell lymphoma; (7)Diffuse large B-cell lymphoma (DLBCL), ineffective after being selected for second-line treatment, or SD or progression of recurrence (PD); B-cell non-Hodgkin lymphoma (B-NHL) patients (immunohistochemistry CD19+) who meet the above pathological classification criteria must also meet the following definition criteria: (1)Recurrent B-NHL: After B-NHL is fully treated to achieve complete remission (CR) or partial remission (PR), disease progression (PD) (primary site or new onset in other sites) occurs; (2)Refractory B-NHL: B-NHL does not achieve complete remission after the last treatment or is ineffective after receiving a systemic treatment regimen, that is, disease progression (PD) or stable disease (SD); 4.Lymphoma has at least one measurable lesion, that is, the length of the lymph node lesion according to the CT cross-sectional image>15mm, or the length of extranodal lesions> 10mm, and FDG-PET examination was positive. (Lugano, 2014); 5.The Eastern Cooperative Oncology Group (ECOG) score =3 months.
Exclusion criteria
Exclusion criteria: 1. Relevant laboratory test values are abnormal (no blood transfusion or G-CSF or other drugs used for correction within 14 days before signing the informed consent): The absolute number of neutrophils =2 ULN; Total bilirubin >=1.5 ULN; Serum creatinine >=2 ULN; Creatinine clearance rate =450 ms, female >=470 ms, QTc interval is calculated by Fridericia formula), uncontrolled hypertension, etc.; 4. Known or suspected NHL affects the central nervous system: -Have or have a current history of relevant central nervous system pathology, such as epilepsy, seizures, paralysis, aphasia, confusion, severe brain injury, cerebellar disease, organic brain syndrome, psychosis; -Brain MRI evidence indicates the presence of inflammatory lesions and/or vasculitis; 5. A history of malignant tumors other than B-cell lymphoma within 5 years before signing the informed consent; except for basal cell carcinoma of the skin or carcinoma in situ of the cervix; 6. Autologous and/or allogeneic stem cell transplantation or organ transplantation has been performed within 12 weeks before the first administration of the study drug; 7. Have received any study monoclonal antibody treatment within 12 weeks before the first administration of the study drug; 8. Have received cancer chemotherapy and/or radiotherapy, other immunotherapy or targeted therapy within 4 weeks before the first administration of the study drug; 9. Receiving the dose of glucocorticoid regularly within 4 weeks before the first administration of the study drug (regular is the regular medication for the treatment of a disease) or expecting to require glucocorticoids such as prednisone to exceed 20 mg/day or its equivalent dose, Or receive any other immunosuppressive treatment within 4 weeks before the first dose of study drug; 10. Human anti-mouse antibody (HAMA) is present, and it is known to be allergic to monoclonal antibody drugs or exogenous human immunoglobulin. 11. Active infections/have not recovered from recent infections; known to have bacteremia, tuberculosis infection in the lungs, etc. 12. Known infection with human immunodeficiency virus (HIV), hepatitis C virus, and chronic hepatitis B [Note: HBsAg (+) is not included in the group; HBsAg (-) and HBV-DNA (+) are not included in the group; HBsAg (-) At the same time HBV-DNA (-) will be evaluated by the investigator for inclusion] and syphilis. 13. Any concomitant disease or medical disease that may interfere with the implementation of the research as judged by the investigator. 14. Fever of unknown cause occurred during the screening period to before the first administration of the drug> 38.5°C (except for the fever caused by the subject's tumor due to the judgment of the investigator). 15. Pregnancy and breastfeeding. 16. Subjects or their partners cannot guarantee that they will take an effective contraceptive measure during their participation in this study and at least 3 months after the end of the study. (See Annex 3 for details) 17. Those who are poor or un
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT that occurred within 28 days after the start of the first medication; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters (CL, Css, T1/2z, Vz);Recommended Phase II dose (RP2D determined based on the obtained safety, tolerability, PK characteristics, etc.);Lymphocyte number and classification;Cytokine levels;Immunogenicity;Anti-tumor efficacy;Adverse events; | — |
Countries
China
Contacts
Public ContactYuqin SONG
Beijing Cancer Hospital
Outcome results
None listed