A Study of MIL62 in Treatment of CD20 Positive B-cell Lymphomas
A Multi-Center, Open Label, Single Arm, Multiple Dose Study to Assess the Tolerability，Pharmacokinetics and Efficacy of MIL62 in Chinese Patients With Relapsed/Refractory CD20+ Malignant B-cell Lymphomas
Lead SponsorBeijing Mabworks Biotech Co., Ltd.
StatusCompleted No Results Posted
Indication/ConditionCD20-positive B Cell Non-Hodgkin Lymphoma
Intervention/TreatmentRecombinant Humanized Monoclonal Antibody MIL62 Injection
This open-label, multicenter,dose-escalating phase I study was designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of MIL62 in Chinese patients with relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma(NHL) for whom no treatment of higher priority was available.
The patients confirming to the eligibility criteria will be assigned to the 5 dose groups (200mg, 400mg, 800mg, 1000mg, and 1500mg, respectively) based on the sequence of inclusion. Each patient received an intravenous infusion of MIL62 on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2-8 for a maximum of 8 cycles and 10 infusions. Each cycle was 21 days.
Inclusion Criteria: Adult patients, >=18 years of age; Diagnosis of Refractory/relapsed CD20+ B-cell lymphoma or B-CLL Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Life expectancy >6 months Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; 3) dose interruptions; and 4) for at least 2 months after discontinuation of all study treatments Able and willing to provide written informed consent and to comply with the study protocol Exclusion Criteria: Prior use of any investigational antibody therapy within 3 months of study start Prior use of any anti-cancer vaccine Prior administration of radioimmunotherapy 3 months prior to study entry Central nervous system lymphoma History of other malignancy Evidence of significant, uncontrolled concomitant disease Abnormal laboratory values Patients with progressive multifocalleukoencephalopathy (PML) Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA ) Known severe allergic reaction or/and infusion reaction to monoclonal antibody.