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

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.

Study Overview

• Status: Completed
• Conditions: CD20-positive B Cell Non-Hodgkin Lymphoma
• Intervention / Treatment: Drug: Recombinant Humanized Monoclonal Antibody MIL62 Injection

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adult patients, >=18 years of age;
2. Diagnosis of Refractory/relapsed CD20+ B-cell lymphoma or B-CLL
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. Life expectancy >6 months
5. 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
6. Able and willing to provide written informed consent and to comply with the study protocol

Exclusion Criteria:

1. Prior use of any investigational antibody therapy within 3 months of study start
2. Prior use of any anti-cancer vaccine
3. Prior administration of radioimmunotherapy 3 months prior to study entry
4. Central nervous system lymphoma
5. History of other malignancy
6. Evidence of significant, uncontrolled concomitant disease
7. Abnormal laboratory values
8. Patients with progressive multifocalleukoencephalopathy (PML)
9. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA )
10. Known severe allergic reaction or/and infusion reaction to monoclonal antibody.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MIL62

Drug: Recombinant Humanized Monoclonal Antibody MIL62 Injection; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Beijing Mabworks Biotech Co., Ltd.
• Investigators: Principal Investigator: Yuankai Shi, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2017
• Primary Completion (Actual): May 30, 2019
• Study Completion (Actual): May 29, 2020

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): June 16, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: 1. CD20-positive 2. lymphomas 3. MIL62
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Antibodies, Monoclonal
• Other Study ID Numbers: MIL62-CT01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No