A Study Comparing SIBP-02 and Rituximab Combination With CHOP in Previously Untreated Subjects With CD20+ DLBCL

Inclusion Criteria:

• 18-75 years old, male or female;
• Patients diagnosed as CD20-positive diffuse large B-cell lymphoma afterhistopathological or cytological examination and untreated;
• ECOG score ≤ 2 when enrolled;
• Echocardiography measured LVEF ≥ 50%;
• The laboratory indicators during the screening period shall meet the followingcriteria: White blood cell count (WBC) ≥ 4.0 × 109/L or the lower limit of normal of the locallaboratory; patients with bone marrow invasion, WBC ≥ 3.0 × 109/L; Absolute neutrophilcount (ANC) ≥ 2.0 × 109/L or the lower limit of normal of the local laboratory; in thepatients with bone marrow invasion, ANC ≥ 1.5 × 109/L; Hemoglobin (HB) ≥ 90 g/L; in thepatients with bone marrow invasion, HB ≥ 80 g/L; Platelets (PLT) ≥ 100 × 109/L; in thepatients with bone marrow invasion, PLT ≥ 75 × 109/L; Total bilirubin ≤ 1.5 times upperlimit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; Alkaline phosphatase ≤ 1.5 × ULN in the patients without bone marrow invasion;Serum creatinine level ≤ 1.5 × ULN;
• Patients having at least one two-dimensional measurable lesion as the basis forevaluation: for intra-nodal lesions, ≥1.5 cm in the long diameter and ≥1.0 cm in theshort diameter; for extra-nodal lesions, ≥1.0 cm in the long diameter;
• Patients with lymphoma International Prognostic Index (IPI) score of 0-2, with stage Ito IV;
• Female at the childbearing age who show negative in the pregnancy test, and agree totake effective contraceptive measures during the study period and within 12 monthsafter the last dose; male patients who agree to take effective contraceptive measuresduring the study period and within 3 months after the last dose;
• Patients with the expected survival period of greater than 6 months;
• Patients voluntary to sign the Informed Consent Form.

Exclusion Criteria:

• Patients with primary central nervous system lymphoma and secondary central nervoussystem invasion, gray zone lymphoma between Burkitt and DLBCL, gray zone lymphomabetween DLBCL and HL, primary mediastinal DLBCL, primary exudative lymphoma,plasmablastic lymphoma, primary skin DLBCL, ALK-positive DLBCL or transformedlymphoma;
• Patients with double hit (BCL-2 and c-MYC gene rearrangement) or triple hit (BCL-2,BCL-6 and c-MYC gene rearrangement) diffuse large B-cell lymphoma diagnosed by theFISH test method; or patients with the pathological immunohistochemical test resultsas follows: BCL-2 ≥70% positive and c-MYC≥40% positive and tumor cells judged to bethe source of germinal center according to Han's evaluation criteria but without exactFISH test result;
• Patients with history of malignant tumors other than cutaneous squamous cellcarcinoma, cutaneous basal cell carcinoma and cervical carcinoma in situ within 5years prior to enrollment;
• Patients with major surgery (excluding diagnostic surgery) within 2 months prior toenrollment;
• Patients treated for non-Hodgkin's lymphoma: Chemotherapy and immunotherapy; Radiotherapy or local radiotherapy for DLBCL; Monoclonalantibody therapy (including Rituxan® and biosimilars of Rituxan®) Surgery (except biopsy);
• Patients previously receiving cytotoxic drugs or anti-CD20 antibodies to treat otherdiseases (e.g. rheumatoid arthritis);
• Patients receiving any monoclonal antibody within 3 months prior to enrollment;
• Patients who participated in other clinical trials and used other trial-related drugswithin 3 months prior to enrollment;
• Those vaccinated within 1 month prior to enrollment;
• Those receiving hematopoietic cytokines, e.g. granulocyte colony-stimulating factor (G-CSF) within 2 weeks prior to enrollment;
• Those with the maximum dose of >100mg Prednisone Acetate Tablets or equivalentcortisols for more than 5 days for the purpose of controlling lymphoma, or with thedaily dose of >30mg Prednisone Acetate Tablets or equivalent cortisols for more than 10 days for the other purposes. For the patients with daily dose of ≤30mg PrednisoneAcetate Tablets or equivalent cortisols, there shall be written record on stable useof pre-randomization dose for at least 4 weeks;
• Patients with peripheral nervous system or central nervous system disorder;
• Patients with suspected active or latent tuberculosis;
• Patients with known uncontrolled active bacterial, viral, fungal, mycobacterial,parasitic or other infections (excluding nail bed fungal infection) or with anysignificant systemic infection event that requires intravenous antibiotic treatment orhospitalization (except for neoplastic fever) within 4 weeks prior to enrollment;
• HIV antibody positive;
• HCV antibody positive;
• HBV infection: (1) HBsAg positive, or (2) HBsAg negative, HBcAb positive and HBV DNA > 1 × 103
• Patients with complicated other diseases that might restrict the patients fromparticipation in the clinical trial in the opinion of the investigator, including butnot limited to: Cardiovascular disease: congestive heart failure (NYHA Class III-IV), unstable angina,poorly controlled arrhythmias, poorly controlled hypertension or hypotension or myocardialinfarction in the past 6 months; Severe mental illness; Gastric ulcer, intestinalinfarction or gastrointestinal perforation (except for ones caused by primary disease);Pulmonary diseases (asthma, interstitial lung disease or severe obstructive pulmonarydisease); Poorly controlled diabetes.
• Patients with contraindication to any drug in the CHOP chemotherapy regime;
• Patients with allergy constitution or known to be allergic to the active ingredient,excipient or rodent product or xenogeneic protein of any drug contained in thisclinical trial (including the CHOP regime);
• Patients unsuitable for enrollment due to alcohol or drug abuse in the opinion of theinvestigator;
• Female in the pregnancy or breast-feeding period;
• Those unsuitable to participate in the clinical trial in the opinion of theinvestigator.