A Study of MIL62 in Treatment of CD20 Positive B-cell Lymphomas

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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CD20-positive B Cell Non-Hodgkin Lymphoma

Intervention / Treatment
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* Drug: Recombinant Humanized Monoclonal Antibody MIL62 Injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MIL62<br> | Drug: Recombinant Humanized Monoclonal Antibody MIL62 Injection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Experienced a Dose-limiting Toxicity in Dose Escalation Period of the Study |  | Baseline to 28 days after the first infusion of MIL62 of the last participant in dose escalation period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Best Overall Response |  | by the end of Cycle 8 (each cycle is 28 days) | 
| Maximum Observed Plasma Concentration (Cmax) Under Steady State of MIL62 |  | by the end of Cycle 4 (each cycle is 28 days) | 
| Area Under the Plasma Concentration Versus Time Curve (AUC) of MIL62 Under Steady State |  | by the end of Cycle 4 (each cycle is 28 days) | 
| Systemic Clearance of MIL62 Under Steady State |  | by the end of Cycle 4 (each cycle is 28 days) | 
| Volume of Distribution Under Steady State (Vss) of MIL62 |  | by the end of Cycle 4 (each cycle is 28 days) | 
| Terminal Plasma Half-Life (t1/2) of MIL62 Under Steady State |  | by the end of Cycle 4 (each cycle is 28 days) | 
| Change in Cluster of Differentiation 19 (CD19+) B Cells |  | by the end of Cycle 4 (each cycle is 28 days) | 
| Change in Cluster of Differentiation 20 (CD20+) B Cells |  | by the end of Cycle 4 (each cycle is 28 days) | 
| Percentage of Participants with Positive Anti-Drug Antibodies to MIL62 |  | by the end of Cycle 4 (each cycle is 28 days) | 
| Progression-free Survival (PFS) in the Study |  | by the end of the follow-up period of the study | 
| Overall Survival (OS) in the Study |  | by the end of the follow-up period of the study | 
| Duration of response (DoR) |  | by the end of the follow-up period of the study | 
| Disease control rate (DCR) |  | by the end of the follow-up period of the study | 
| Participants With Event-Free Survival (EFS) |  | by the end of the follow-up period of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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1. CD20-positive 2. lymphomas 3. MIL62