- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04103905
A Study of MIL62 in Treatment of CD20 Positive B-cell Lymphomas
June 15, 2021 updated by: Beijing Mabworks Biotech Co., Ltd.
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Beijing
-
Beijing, Beijing, China, 100021
- Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- Adult patients, >=18 years of age;
- Diagnosis of Refractory/relapsed CD20+ B-cell lymphoma or B-CLL
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy >6 months
- 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
- Able and willing to provide written informed consent and to comply with the study protocol
Exclusion Criteria:
- Prior use of any investigational antibody therapy within 3 months of study start
- Prior use of any anti-cancer vaccine
- Prior administration of radioimmunotherapy 3 months prior to study entry
- Central nervous system lymphoma
- History of other malignancy
- Evidence of significant, uncontrolled concomitant disease
- Abnormal laboratory values
- Patients with progressive multifocalleukoencephalopathy (PML)
- Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA )
- Known severe allergic reaction or/and infusion reaction to monoclonal antibody.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MIL62
|
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
Time Frame: Baseline to 28 days after the first infusion of MIL62 of the last participant in dose escalation period
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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
Time Frame: by the end of Cycle 8 (each cycle is 28 days)
|
by the end of Cycle 8 (each cycle is 28 days)
|
Maximum Observed Plasma Concentration (Cmax) Under Steady State of MIL62
Time Frame: by the end of Cycle 4 (each cycle is 28 days)
|
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
Time Frame: by the end of Cycle 4 (each cycle is 28 days)
|
by the end of Cycle 4 (each cycle is 28 days)
|
Systemic Clearance of MIL62 Under Steady State
Time Frame: by the end of Cycle 4 (each cycle is 28 days)
|
by the end of Cycle 4 (each cycle is 28 days)
|
Volume of Distribution Under Steady State (Vss) of MIL62
Time Frame: by the end of Cycle 4 (each cycle is 28 days)
|
by the end of Cycle 4 (each cycle is 28 days)
|
Terminal Plasma Half-Life (t1/2) of MIL62 Under Steady State
Time Frame: by the end of Cycle 4 (each cycle is 28 days)
|
by the end of Cycle 4 (each cycle is 28 days)
|
Change in Cluster of Differentiation 19 (CD19+) B Cells
Time Frame: by the end of Cycle 4 (each cycle is 28 days)
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by the end of Cycle 4 (each cycle is 28 days)
|
Change in Cluster of Differentiation 20 (CD20+) B Cells
Time Frame: by the end of Cycle 4 (each cycle is 28 days)
|
by the end of Cycle 4 (each cycle is 28 days)
|
Percentage of Participants with Positive Anti-Drug Antibodies to MIL62
Time Frame: by the end of Cycle 4 (each cycle is 28 days)
|
by the end of Cycle 4 (each cycle is 28 days)
|
Progression-free Survival (PFS) in the Study
Time Frame: by the end of the follow-up period of the study
|
by the end of the follow-up period of the study
|
Overall Survival (OS) in the Study
Time Frame: by the end of the follow-up period of the study
|
by the end of the follow-up period of the study
|
Duration of response (DoR)
Time Frame: by the end of the follow-up period of the study
|
by the end of the follow-up period of the study
|
Disease control rate (DCR)
Time Frame: by the end of the follow-up period of the study
|
by the end of the follow-up period of the study
|
Participants With Event-Free Survival (EFS)
Time Frame: by the end of the follow-up period of the study
|
by the end of the follow-up period of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yuankai Shi, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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