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

NCT ID: NCT04103905

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-10
• Study Completion Date: 2020-05-29

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.

Conditions

CD20-positive B Cell Non-Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MIL62

Group Type: EXPERIMENTAL

Recombinant Humanized Monoclonal Antibody MIL62 Injection

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Mabworks Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuankai Shi

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

MIL62-CT01

Identifier Type: -

Identifier Source: org_study_id