CD20-positive B Cell Non-Hodgkin LymphomaPhase 1NCT04103905
A Study of MIL62 in Treatment of CD20 Positive B-cell Lymphomas
A Phase 1 study testing Recombinant Humanized Monoclonal Antibody MIL62 Injection in people with CD20-positive B Cell Non-Hodgkin Lymphoma, run by Beijing Mabworks Biotech Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CD20-positive B Cell Non-Hodgkin Lymphoma
- What is being tested?
- Recombinant Humanized Monoclonal Antibody MIL62 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2017to 29 May 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)
Beijing, Beijing Municipality, 100021
About this study
Official title: 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.
- Being tested
- Recombinant Humanized Monoclonal Antibody MIL62 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Humanized Monoclonal Antibody MIL62 InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| MIL62 | Experimental | Not described Receives: Drug: Recombinant Humanized Monoclonal Antibody MIL62 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Experienced a Dose-limiting Toxicity in Dose Escalation Period of the Study
Measured: Baseline to 28 days after the first infusion of MIL62 of the last participant in dose escalation period
Secondary outcomes (14)
Percentage of Participants With Best Overall Response
Measured: by the end of Cycle 8 (each cycle is 28 days)
Maximum Observed Plasma Concentration (Cmax) Under Steady State of MIL62
Measured: 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
Measured: by the end of Cycle 4 (each cycle is 28 days)
Systemic Clearance of MIL62 Under Steady State
Measured: by the end of Cycle 4 (each cycle is 28 days)
Volume of Distribution Under Steady State (Vss) of MIL62
Measured: by the end of Cycle 4 (each cycle is 28 days)
Terminal Plasma Half-Life (t1/2) of MIL62 Under Steady State
Measured: by the end of Cycle 4 (each cycle is 28 days)
Change in Cluster of Differentiation 19 (CD19+) B Cells
Measured: by the end of Cycle 4 (each cycle is 28 days)
Change in Cluster of Differentiation 20 (CD20+) B Cells
Measured: by the end of Cycle 4 (each cycle is 28 days)
Percentage of Participants with Positive Anti-Drug Antibodies to MIL62
Measured: by the end of Cycle 4 (each cycle is 28 days)
Progression-free Survival (PFS) in the Study
Measured: by the end of the follow-up period of the study
Overall Survival (OS) in the Study
Measured: by the end of the follow-up period of the study
Duration of response (DoR)
Measured: by the end of the follow-up period of the study
Disease control rate (DCR)
Measured: by the end of the follow-up period of the study
Participants With Event-Free Survival (EFS)
Measured: by the end of the follow-up period of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start10 Feb 2017
- Primary completion30 May 2019
- Study completion29 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CD20-positive B Cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Beijing Mabworks Biotech Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Mabworks Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuankai Shi, Principal investigator, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103905
- Sponsor's protocol ID
- MIL62-CT01
- Status last verified
- Aug 2019
- First submitted
- 18 Sep 2019
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04103905
- Acronym / sponsor ID
- MIL62-CT01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Beijing Mabworks Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 29 May 2020 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MIL62 | Experimental | Drug: Recombinant Humanized Monoclonal Antibody MIL62 Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Humanized Monoclonal Antibody MIL62 InjectionThe 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. | Drug | MIL62 |
Primary outcome
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
14 secondary outcomes
Percentage of Participants With Best Overall Response
Time frame: 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)
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)
Systemic Clearance of MIL62 Under Steady State
Time frame: 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)
Terminal Plasma Half-Life (t1/2) of MIL62 Under Steady State
Time frame: 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)
Change in Cluster of Differentiation 20 (CD20+) B Cells
Time frame: 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)
Progression-free Survival (PFS) in the Study
Time frame: 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
Duration of response (DoR)
Time frame: 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
Participants With Event-Free Survival (EFS)
Time frame: by the end of the follow-up period of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuankai Shi principal investigator
Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant Humanized Monoclonal Antibody MIL62 Injection in people with CD20-positive B Cell Non-Hodgkin Lymphoma, run by Beijing Mabworks Biotech Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.