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Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (NHL)Phase 1NCT05155839

Safety and Preliminary Efficacy Study of MRG001 in Patients With Non-Hodgkin Lymphoma (NHL)

A Phase 1 study testing MRG001 in people with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (NHL), run by Shanghai Miracogen Inc. at 12 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study consists of two parts. Phase Ia is a dose escalation study to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of MRG001. Phase Ib is a dose expansion study to assess the preliminary efficacy of MRG001 in patients with CD20-positive relapsed or refractory B-cell NHL at the… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
MRG001
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
12 sitesChina
Study dates
25 Jun 2019to Oct 2023
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily participates in the clinical study; Fully understands and informed of this study, and provides written informed consent; Willing to follow and have the ability to complete all trial procedures.
  • Aged 18 to 80 (including 18 and 80), male or female.
  • Patients with histopathologically confirmed relapsed/refractory B-cell non-Hodgkin lymphoma.
  • Relapsed or refractory disease after standard of care treatment with anti-CD20 antibodies.
  • Patients must have at least one measurable lesion without prior local therapy according to Lugano 2014 criteria.
  • The score of ECOG for performance status is 0 or 1.
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  • Patients without severe hematopoietic, liver and kidney dysfunction.
  • Expected survival time ≥ 3 months.
  • Prior anti-tumor treatment-related AEs (NCI CTCAE v5.0 Criteria) have recovered to ≤ Grade 1.
  • Negative blood pregnancy test for women of childbearing potential within 7 days prior to the first dose of study drug. Patients of childbearing potential should agree to use effective contraception from signing the ICF until 3 months after the last dose of study drug.
  • The score of left ventricular ejection fraction (LVEF) is > 50%.

Who cannot join

  • Applicable to Phase Ia: positive hepatitis B surface antigen (HBsAg), or negative HBsAg with a peripheral blood hepatitis B virus DNA copy number greater than the upper limit of normal; positive hepatitis C virus (HCV) antibody and positive HCV RNA at screening. Patients with a history of clinically significant non-viral hepatitis and cirrhosis. Applicable to Phase Ib: positive hepatitis B surface antigen (HBsAg) and/or positive hepatitis B core antibody (HBcAb) at screening, and peripheral blood hepatitis B virus DNA copy number greater than the upper limit of normal; positive hepatitis C virus (HCV) antibody and positive HCV RNA. Patients with a history of clinically significant non-viral hepatitis and cirrhosis (decompensated cirrhosis Child-Pugh class B, C).
  • Positive human immunodeficiency virus (HIV) antibody.
  • Any active infection requiring systemic therapy occurred within 2 weeks before enrollment.
  • Suspected or confirmed central nervous system invasion of NHL.
  • Allergic constitution or known hypersensitivity to rituximab or other anti-CD20 monoclonal antibodies and their components, or hypersensitivity to any component of MRG001.
  • Patients with uncontrolled or significant cardiovascular disease.
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  • History of severe pulmonary disease.
  • Received CAR-T therapy within 3 months before enrollment.
  • Received blood transfusion within 28days before enrollment, or receiced erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF) and other drugs that may affect hemogram within 14 days before enrollment.
  • Current use of potent CYP3A4 inhibitors or inducers.
  • History of allogeneic stem cell transplantation or organ transplantation, or have received autologous stem cell transplantation within 3 months prior to screening, or plan to undergo stem cell transplantation.
  • Suffered from other malignancies within the last 5 years.
  • Major surgery within 6 weeks prior to enrollment or planned major surgery within the first 12 weeks after receiving study drug.
  • Patients who are receiving any approved or investigational anti-tumor treatment with antibody/fusion protein/ADC drugs, radiotherapy, chemotherapy, Chinese patent medicine or Chinese herbal medicine within 28 days before enrollment; or have participated in any approved or investigational small molecule targeted therapy within 28 days before enrollment or within 5 half-lives (whichever is shorter).
  • Received any vaccine within 28 days prior to enrollment or will receive any vaccine within 6 months after the last dose of study drug.
  • Requires treatment with glucocorticoids or other immunosuppressive agents for a certain condition within 14 days prior to enrollment.
  • An acute oncolytic reaction may occur at the discretion of the investigator.
  • Inability to complete protocol-specified study visits and study drug administration.
  • Women during pregnancy or lactation; men and women of childbearing potential who are unwilling to take prescribed appropriate contraceptive measures.
  • Other conditions inappropriate for participation in this clinical trial at the discretion of the investigator.
  • Malignant lymphoma with pathological transformation.
  • High-grade B-cell lymphoma.
  • Patient's Body Mass Index ≤ 17 kg/m2.
  • Patients with underlying medical conditions that, in the judgment of the investigator, might increase the risk of receiving study drug or might affect the safety assessment of the study drug.

Trial locations and contacts

12 sites in 1 country.

Program Director, Master contact

86-21-61637960 ext. 8050

clinicaltrials@miracogen.com.cn

12 sites in 1 country

China12 sites, 12 recruiting

  • Beijing Friendship Hospital

    Beijing, Beijing Municipality, 100050

    Zhao Wang

    Recruiting

  • Peking University Cancer Hospital & Institute

    Beijing, Beijing Municipality, 100142

    Jun Zhu, Doctor, zhujun3346@163.com.cn

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    Yu Yang, Doctor

    Recruiting

  • Sun Yat-sen University Cancer Hospital

    Guangzhou, Guangdong, 510075

    Qingqing Cai, Doctor

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

    Wenyu Li, Doctor

    Recruiting

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510280

    Yuhua Li, Doctor

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310005

    Haiyan Yang, Doctor

    Recruiting

  • Harbin First Hospital

    Harbin, Heilongjiang, 150010

    Jun Ma, Doctor

    Recruiting

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200120

    Ye Guo, Doctor, pattrickguo@gmail.com

    Recruiting

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110001

    Xiaojing Yan, Doctor

    Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

    Zhuogang Liu, Doctor

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

    Keshu Zhou, Doctor

    Recruiting

Other trials in China

About this study

Official title: An Open-label, Multicenter, First-in-human, Phase I Dose-escalation and Expansion Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of MRG001 in Patients With CD20-positive Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (NHL)

This study consists of two parts. Phase Ia is a dose escalation study to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of MRG001. Phase Ib is a dose expansion study to assess the preliminary efficacy of MRG001 in patients with CD20-positive relapsed or refractory B-cell NHL at the confirmed RP2D. The safety, tolerability, pharmacokinetic (PK) and immunogenicity of MRG001 will be evaluated in both parts.

Being tested
MRG001
Keywords
MRG001, Antibody Drug Conjugate (ADC), CD20, Non-Hodgkin lymphoma (NHL)
Medical subject headings
Recurrence, Lymphoma, B-Cell, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRG001Drug

    Administrated intravenously

Study groups in NCT05155839
Study groupRoleWhat they receive
MRG001ExperimentalAll patients in Phase Ia (dose escalation) and Phase Ib (dose expansion) will be administrated MRG001 on Day 1 of every 3 weeks (21-day cycle).
Receives: Drug: MRG001

What is being measured

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

  1. Adverse Events (AEs)

    Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug.

    Measured: Baseline to 90 days after the last dose of study treatment.

  2. Maximum Tolerated Dose (MTD)

    The highest dose confirmed wherein ≤ 1/6 of patients in a treatment cohort experiences a dose-limiting toxicity (DLT) within 21 days after the first dose of study treatment.

    Measured: DLT will be evaluated during the first treatment cycle (Day 1-21).

  3. Recommended Phase II Dose (RP2D)

    The dose level of MRG001 recommended for further phase II clinical studies.

    Measured: Baseline to study completion (up to 15 months).

Secondary outcomes (7)

  1. PK parameter: Concentration-time curve

    Plot of drug concentration changing with time after drug administration.

    Measured: Baseline to 90 days after the last dose of study treatment.

  2. Immunogenicity

    The proportion of patients with positive ADA immunogenicity results.

    Measured: Baseline to 30 days after the last dose of study treatment

  3. Objective Response Rate (ORR)

    ORR is defined as the proportion of subjects with CR and PR.

    Measured: Baseline to study completion (up to 15 months)

  4. Duration of Response (DoR)

    DoR is defined as the duration from the initial recording of objective disease response to the first onset of tumor progression, or death of any cause.

    Measured: Baseline to study completion (up to 15 months)

  5. Disease Control Rate (DCR)

    DCR is defined as the percentage of patients who achieve CR, PR, and stable disease (SD) after treatment.

    Measured: Baseline to study completion (up to 15 months)

  6. Progression Free Survival (PFS)

    PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.

    Measured: Baseline to study completion (up to 15 months)

  7. Overall Survival (OS)

    OS is defined as the duration from the start of treatment to death of any cause.

    Measured: Baseline to study completion (up to 15 months)

Timeline

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

  1. First posted14 Dec 2021
  2. Study start25 Jun 2019
  3. Primary completionOct 2022 (estimated)
  4. Study completionOct 2023 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05155839
Sponsor's protocol ID
MRG001-001
Status last verified
Feb 2022
First submitted
1 Dec 2021
Last updated
22 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MRG001 in people with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (NHL), run by Shanghai Miracogen Inc. at 12 sites 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 11 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites 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?

Results are not available in the source record.

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

Contact Program Director, Master (86-21-61637960 ext. 8050, clinicaltrials@miracogen.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (AEs) (time frame: Baseline to 90 days after the last dose of study treatment.). The study lists 3 primary outcomes in all. 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 NCT05155839.

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 22 Feb 2022.

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