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

Phase 1

Completed

• Conditions: CD20-positive B Cell Non-Hodgkin Lymphoma
• Interventions: Drug: Recombinant Humanized Monoclonal Antibody MIL62 Injection

• Registration Number: NCT04103905
• Lead Sponsor: Beijing Mabworks Biotech Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-10
• Primary Completion: 2019-05-30
• Status Verified: 2019-08
• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-24
• Study First Posted: 2019-09-26
• Study Completion: 2020-05-29
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MIL62	Recombinant Humanized Monoclonal Antibody MIL62 Injection	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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
Participants With Event-Free Survival (EFS)	by the end of the follow-up period of the study
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)
Change in Cluster of Differentiation 19 (CD19+) 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)
Duration of response (DoR)	by the end of the follow-up period of the study
Systemic Clearance of MIL62 Under Steady State	by the end of Cycle 4 (each cycle is 28 days)
Disease control rate (DCR)	by the end of the follow-up period of the study
Change in Cluster of Differentiation 20 (CD20+) B Cells	by the end of Cycle 4 (each cycle is 28 days)

Trial Locations

Locations (1)

Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC); 🇨🇳 Beijing, Beijing, China