Phase
Condition
Lymphoma
Non-hodgkin's Lymphoma
Cancer/tumors
Treatment
MBS303
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Able and willing to provide written informed consent and to comply with the studyprotocol.
Adult patients, ≥18 years of age;
CD20+ B-cell Non-Hodgkin Lymphoma who have relapsed after or failed to respond to atleast one prior treatment regimen with an anti-CD20 monoclonal antibody and for whomthere is no available therapy expected to improve survival;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Life expectancy ≥3 months;
Measurable disease, defined as at lease one bi-dimensionally measurable nodallesion, defined as >1.5 cm in its longest dimension, or at least onebi-dimensionally measureable extranodal lesion, defined as >1.0 cm in its longestdimension
Adequate hematologic, hepatic, and renal function.
Exclusion
Exclusion Criteria:
Chronic lymphoblastic leukemia, Burkitt lymphoma or lymphoplasmacytic lymphom;
History of central nervous system (CNS) lymphoma or other CNS disease;
Participants with known active infection, including bacterial, viral, parasite,mycobacterial, or other infections (excluding nail bed fungal infections);
Surgery, chemotherapy, targeted therapy, immunotherapy, radiation therapy, tumorembolization, or other antitumor therapy within 28 days prior to the first MBS303;
Active or suspected autoimmune diseases;
Known severe allergic reaction or/and infusion reaction to monoclonal antibody;
Evidence of significant, uncontrolled concomitant disease;
Major surgery within 28 days prior to the first MBS303 administration or expected toundergo major surgery during the study treatment;
History of another invasive malignant tumors in past 3 years;
Participant with history of confirmed progressive multifocal leukoencephalopathy (PML);
Severe hemorrhagic diseases such as hemophilia A, hemophilia B, vascular hemophilia,or spontaneous bleeding requiring blood transfusion or other medical intervention;
Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C (including HBsAg, HBcAb positive with abnormal HBV DNA or HCV RNA);
Pregnant or lactating women; Females of childbearing potential (FCBP) must agree touse two reliable forms of contraception simultaneously or to practice completeabstinence from heterosexual contact during the following time periods related tothis study: 1) while participating in the study; 2) for at least 12 months afterdiscontinuation of all study treatments.
Study Design
Connect with a study center
Beijing Cancer Hospital
Beijing,
ChinaActive - Recruiting
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