| Eligibility |
Inclusion Criteria:
To be eligible for study entry subjects must satisfy all of the following criteria: 1. Must
be willing to provide written consent 2. Male or female, 18 years old or older 3.
Histopathology test confirmed CD20-positive patients with relapsed/refractory/progressive
non-Hodgkin's lymphoma, who have been treated with at least one course of standard
anti-tumor regimen; 4. Has at least one measurable lesion: CLL patient monoclonal B
cells=5x 10^9/L. IgM in WM patients is greater than 2 times of the upper limit of normal.
In patients other than CLL and WM, any diameter of the lymph node lesion =1.5cm or any
extranodal lesion >1cm; 5. If the previous radiotherapy and chemotherapy cause toxic side
effects, it needs to be restored to at least level 1 or returned to the baseline value or
to be judged as irreversible (except for neurotoxicity related to grade 2 alopecia or
platinum-containing treatment); 6. The patient's ECOG score was 0-2 points; 7. Expected
survival is at least 6 months; 8. Subjects must have appropriate organ function and meet
all of the following laboratory findings prior to enrollment: 1) The bone marrow reserve
was basically normal: neutrophils (ANC) = 1.0 × 10^9/L, hemoglobin (HB) = 70 g/L, platelets
(PLT) = 50×10^9/L (Except for bone marrow invasion, B-NHL-related autoimmune cytopenia.
bone marrow invasion will be judged by bone marrow biopsy, bone marrow smear, and bone
marrow flow cytology results.) 2) Liver function is basically normal: ALT = 2.5×ULN, AST =
2.5×ULN, TBIL = 1.5×ULN (except for liver invasion. Patients with B-NHL-related autoimmune
hemolytic anemia, TBIL is not subject to this limit); 3) Renal function is basically
normal: creatinine = 1.5×ULN, or creatinine clearance = 60mL/min; 4) The conventional
coagulation examinations is basically normal: INR = 1.5×ULN, APTT does not exceed the
normal reference for 10 seconds; 9. Fertile female must be tested negative for serum
pregnancy test; 10. If the patient is a male, it must be a male who has undergone surgical
birth control, or use of an effective contraceptive method during the study period and
within 12 months after the study drug is discontinued. In the case of female, an effective
contraceptive procedure must be taken or during menopause or use of an effective
contraceptive method during the study period and within 12 months of the study drug
discontinuation, and avoid breastfeeding during the study period and within 12 months of
the study drug discontinuation.
Exclusion Criteria:
Subjects will be excluded from the study if one or more of the following criteria are
applicable: 1. Treatment with any monoclonal antibody within 3 months prior to the first
dose; 2. Have used any anti-cancer vaccine in the past, or have used the HPV vaccine within
3 months prior to the study; 3. Used anti-CD20 mAb within 3 months prior to the first dose;
4. Radioimmunotherapy was used within 3 months prior to the first dose; 5. Treatment of
transfusion, erythropoietin, granulocyte colony-stimulating factor or
granulocyte-macrophage colony-stimulating factor within 2 weeks prior to the first dose; 6.
Hematopoietic stem cell transplantation was performed 3 months before the first
administration or hematopoietic stem cell transplantation was planned in 3 months; 7. A
history of severe allergic reactions to humanized or murine monoclonal antibodies. (or is
high reactivity / allergy to murine-derived products); 8. Evidence or medical history of
central nervous system invasion or cranial neuropathy; 9. Concurrent with other malignant
tumors (except for in situ cervical cancer, skin cancer, complete remission > 5 years of
breast cancer and melanoma); 10. Other serious, uncontrollable concomitant diseases,
including but not limited to: active infections, uncontrolled diabetes, uncontrollable
hypertension, etc.; 11. Major surgery performed within 4 weeks prior to the first dose or
during the expected study period, or if the surgical wound is not healed; 12. Patients with
rheumatoid arthritis, granulomatous vasculitis, microscopic polyangiitis, toxic epidermal
necrolysis or Stevens-Johnson syndrome; 13. Patients with chronic idiopathic bowel disease
(including history of Crohns disease and Ulcerative Colitis), with intestinal obstruction
or with chronic diarrhea; 14. Other past history, acute or chronic disease, mental illness,
or laboratory test abnormalities that may result in increased risk of involvement in study
or study drug administration, or interference in interpretation of research findings; 15.
Pregnant or lactating women; 16. Received treatment in another clinical study within 4
weeks prior to the first dose; 17. Patients receiving high-dose corticosteroids
(prednisolone greater than 10 mg/day or equivalent dosage of other drugs for 2 weeks or
more) within 4 weeks prior to the first dose; 18. Virological examination: HBsAg positive;
HBcAb positive and HBV-DNA detection = detection upper limit; HCV antibody positive; HIV
antibody positive; syphilis infection positive. 19. Subject is considered by the
investigator, for any reason, to be an unsuitable candidate for the study.
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