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

NCT04103905 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-05-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Beijing Mabworks Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yuankai Shi · Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-10
Primary Completion
2019-05-30
Completion
2020-05-29

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04103905 on ClinicalTrials.gov