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

Beijing Mabworks Biotech

Status and phase: Completed; Phase 1

Conditions: CD20-positive B Cell Non-Hodgkin Lymphoma

Treatments: Drug: Recombinant Humanized Monoclonal Antibody MIL62 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04103905

MIL62-CT01

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

MIL62

Experimental group

Treatment:

Drug: Recombinant Humanized Monoclonal Antibody MIL62 Injection