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

Primary Purpose

CD20-positive B Cell Non-Hodgkin Lymphoma

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Recombinant Humanized Monoclonal Antibody MIL62 Injection

About this trial

This is an interventional treatment trial for CD20-positive B Cell Non-Hodgkin Lymphoma focused on measuring 1. CD20-positive 2. lymphomas 3. MIL62

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MIL62

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants Who Experienced a Dose-limiting Toxicity in Dose Escalation Period of the Study

Secondary Outcome Measures

Percentage of Participants With Best Overall Response

Maximum Observed Plasma Concentration (Cmax) Under Steady State of MIL62

Area Under the Plasma Concentration Versus Time Curve (AUC) of MIL62 Under Steady State

Systemic Clearance of MIL62 Under Steady State

Volume of Distribution Under Steady State (Vss) of MIL62

Terminal Plasma Half-Life (t1/2) of MIL62 Under Steady State

Change in Cluster of Differentiation 19 (CD19+) B Cells

Change in Cluster of Differentiation 20 (CD20+) B Cells

Percentage of Participants with Positive Anti-Drug Antibodies to MIL62

Progression-free Survival (PFS) in the Study

Overall Survival (OS) in the Study

Duration of response (DoR)

Disease control rate (DCR)

Participants With Event-Free Survival (EFS)

Full Information

NCT ID

NCT04103905

First Posted

September 18, 2019

Last Updated

June 15, 2021

Sponsor

Beijing Mabworks Biotech Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04103905

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

February 10, 2017 (Actual)

Primary Completion Date

May 30, 2019 (Actual)

Study Completion Date

May 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beijing Mabworks Biotech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

CD20-positive B Cell Non-Hodgkin Lymphoma

Keywords

1. CD20-positive 2. lymphomas 3. MIL62

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MIL62

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Recombinant Humanized Monoclonal Antibody MIL62 Injection

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percentage of Participants Who Experienced a Dose-limiting Toxicity in Dose Escalation Period of the Study

Time Frame

Baseline to 28 days after the first infusion of MIL62 of the last participant in dose escalation period

Secondary Outcome Measure Information:

Title

Percentage of Participants With Best Overall Response

Time Frame

by the end of Cycle 8 (each cycle is 28 days)

Title

Maximum Observed Plasma Concentration (Cmax) Under Steady State of MIL62

Time Frame