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Follicular Lymphoma and Marginal Zone LymphomaPhase 1/2NCT04110301

MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL)

A Phase 1/2 study testing Recombinant Humanized Monoclonal Antibody MIL62 Injection and Lenalidomide in people with Follicular Lymphoma and Marginal Zone Lymphoma, run by Beijing Mabworks Biotech Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This phase 1b/2 trial studies the safety and best dose of lenalidomide when given together with MIL62 and how well this combination works in treating patients with Relapsed/Refractory low-grade Follicular Lymphoma(FL) and Marginal Zone Lymphoma(MZL). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Recombinant Humanized Monoclonal Antibody MIL62 Injection and Lenalidomide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteChina
Study dates
28 Nov 2019to May 2025
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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;
  • Patients with either histologically documented CD20-positive MZL or FL, WHO grade 1, 2 or 3a
  • Evidence of progression or lack of response following at least 1 prior treatment
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • At least one bi-dimensionally measurable nodal or tumor lesion defined by CT scan as: greatest transverse diameter > 1.5 cm and a short axis ≥ 10mm
  • Adequate hematologic function (unless abnormalities are related to NHL)
  • Life expectancy >6 months
  • Able and willing to provide written informed consent and to comply with the study protocol

Who cannot join

  • Evidence ongoing transformation into aggressive NHL
  • Central nervous system lymphoma
  • Patients with progressive multifocalleukoencephalopathy (PML)
  • Prior use of any antibody therapy(except for Rituximab ) within 3 months of study start
  • Prior use of any anti-cancer vaccine
  • Prior administration of radiotherapy 42 days prior to study entry
Show all 14Show fewer
  • Prior administration of chemotherapy 28 days prior to study entry
  • History of prior malignancy within the last 3 years, with the exception of curatively treated basal or squamous cell carcinoma of the skin and low-grade in situ carcinoma of the cervix
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
  • Known hypersensitivity to thalidomide or lenalidomide
  • Regular treatment with corticosteroids prior to the start of cycle 1, unless administered for indications other than NHL at a dose equivalent to < 20 mg/day prednisone
  • Any serious active disease or co-morbid medical condition (such as New York Heart Association Class II or IV cardiac disease, severe arrhythmia, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm or other according to investigator's decision)
  • Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA )
  • Pregnant or lactating females

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yuankai Shi, MD contact

(+86)010-87788293

syuankaipumc@126.com

China1 site, 1 recruiting

  • Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing

    Yuankai Shi, doctor

    Recruiting

Other trials in China

About this study

Official title: A Multi-center, Open Label, Phase 1b/2 Study to Study the Efficacy and Safety of MIL62 Plus Lenalidomide in Subjects With Relapsed/Refractory Follicular Lymphoma or Marginal Zone Lymphoma

This phase 1b/2 trial studies the safety and best dose of lenalidomide when given together with MIL62 and how well this combination works in treating patients with Relapsed/Refractory low-grade Follicular Lymphoma(FL) and Marginal Zone Lymphoma(MZL). Giving MIL62 plus lenalidomide may work better in indolent Non-Hodgkin Lymphoma(NHL).

Read the detailed description

The Aim of this phase 1b/2 trial (MIL62 Plus Lenalidomide) is to find the safety and best dose of lenalidomide when given together with MIL62 and how well this combination works in treating patients with Relapsed/Refractory low-grade Follicular Lymphoma(FL) and Marginal Zone Lymphoma(MZL). Giving MIL62 plus lenalidomide may work better in indolent Non-Hodgkin Lymphoma(NHL).

Being tested
Recombinant Humanized Monoclonal Antibody MIL62 Injection, Lenalidomide
Keywords
CD20 ,Follicular Lymphoma,Marginal Zone Lymphoma,MIL62
Medical subject headings
Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone

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

    Also called MIL62

    1000mg /dose for 12 cycles(28 days) and a total of 11 doses :the first Cycle(Day1,Day15), the 2nd-8th Cycles(Day 1 every cycle);the 9th-12nd Cycles (One dose every two cycles).

  • LenalidomideDrug

    Also called Revlimid

    Dose on days 2-22 every 28 days x 12 cycles: the starting dose is 10-mg ; Adjusted dose according to the tumor response or toxicity reaction

Study groups in NCT04110301
Study groupRoleWhat they receive
MIL62 + LenalidomideExperimentalMIL62 plus Lenalidomide
Receives: Drug: Recombinant Humanized Monoclonal Antibody MIL62 Injection; Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With an Objective Response of Complete Response

    Percentage of Participants With an Objective Response of Complete Response

    Measured: Baseline to 1 month after the last dose of last patient

Secondary outcomes (4)

  1. Kaplan-Meier Estimate of Duration of Response

    Kaplan-Meier Estimate of Duration of Response

    Measured: Baseline to 1 month after the last dose of last patient

  2. Percentage of Participants With Disease Control

    Percentage of Participants With Disease Control

    Measured: Baseline to 1 month after the last dose of last patient

  3. Participants With 1 Year Progression Free Survival

    Participants With 1 Year Progression Free Survival

    Measured: Baseline to 1 month after the last dose of last patient

  4. Number of Participants With Treatment Emergent Adverse Events

    Number of Participants With Treatment Emergent Adverse Events

    Measured: up to the 1 month the last dose of last subject

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2019
  2. Study start28 Nov 2019
  3. Primary completion9 Jan 2024
  4. Study completionMay 2025 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04110301
Sponsor's protocol ID
MIL62-CT02
Status last verified
Oct 2024
First submitted
27 Sep 2019
Last updated
20 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Shi Y, Zhou K, Zhou H, Qin Y, Jing H, Xiang Y, Wang Z, Wang Z, Zang A, Bai O, Li Z, Zhang H, Song Y, Liang J, Wei M. Efficacy and safety of MIL62, a novel glycoengineered type Ⅱ anti-CD20 monoclonal antibody, combined with lenalidomide in patients with relapsed/refractory follicular lymphoma or marginal zone lymphoma: a multicentre, single-arm, phase 1b/2 trial. EClinicalMedicine. 2024 Jun 20;73:102702. doi: 10.1016/j.eclinm.2024.102702. eCollection 2024 Jul.

    PubMed 39007066

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Recombinant Humanized Monoclonal Antibody MIL62 Injection and Lenalidomide in people with Follicular Lymphoma and Marginal Zone 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 8 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 20 Nov 2024. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yuankai Shi, MD ((+86)010-87788293, syuankaipumc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With an Objective Response of Complete Response (time frame: Baseline to 1 month after the last dose of last patient). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04110301, which also lists 1 linked publication.

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 20 Nov 2024; AzTrials last refreshed its copy on 2 Nov 2026.

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