Safety and Preliminary Efficacy Study of MRG001 in Patients With Non-Hodgkin Lymphoma (NHL)
NCT ID: NCT05155839
Last Updated: 2022-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
108 participants
INTERVENTIONAL
2019-06-25
2023-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MRG001
All 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).
MRG001
Administrated intravenously
Interventions
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MRG001
Administrated intravenously
Eligibility Criteria
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Inclusion Criteria
2. Aged 18 to 80 (including 18 and 80), male or female.
3. Patients with histopathologically confirmed relapsed/refractory B-cell non-Hodgkin lymphoma.
4. Relapsed or refractory disease after standard of care treatment with anti-CD20 antibodies.
5. Patients must have at least one measurable lesion without prior local therapy according to Lugano 2014 criteria.
6. The score of ECOG for performance status is 0 or 1.
7. Patients without severe hematopoietic, liver and kidney dysfunction.
8. Expected survival time ≥ 3 months.
9. Prior anti-tumor treatment-related AEs (NCI CTCAE v5.0 Criteria) have recovered to ≤ Grade 1.
10. 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.
11. The score of left ventricular ejection fraction (LVEF) is \> 50%.
Exclusion Criteria
2. Positive human immunodeficiency virus (HIV) antibody.
3. Any active infection requiring systemic therapy occurred within 2 weeks before enrollment.
4. Suspected or confirmed central nervous system invasion of NHL.
5. Allergic constitution or known hypersensitivity to rituximab or other anti-CD20 monoclonal antibodies and their components, or hypersensitivity to any component of MRG001.
6. Patients with uncontrolled or significant cardiovascular disease.
7. History of severe pulmonary disease.
8. Received CAR-T therapy within 3 months before enrollment.
9. 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.
10. Current use of potent CYP3A4 inhibitors or inducers.
11. 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.
12. Suffered from other malignancies within the last 5 years.
13. Major surgery within 6 weeks prior to enrollment or planned major surgery within the first 12 weeks after receiving study drug.
14. 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).
15. Received any vaccine within 28 days prior to enrollment or will receive any vaccine within 6 months after the last dose of study drug.
16. Requires treatment with glucocorticoids or other immunosuppressive agents for a certain condition within 14 days prior to enrollment.
17. An acute oncolytic reaction may occur at the discretion of the investigator.
18. Inability to complete protocol-specified study visits and study drug administration.
19. Women during pregnancy or lactation; men and women of childbearing potential who are unwilling to take prescribed appropriate contraceptive measures.
20. Other conditions inappropriate for participation in this clinical trial at the discretion of the investigator.
21. Malignant lymphoma with pathological transformation.
22. High-grade B-cell lymphoma.
23. Patient's Body Mass Index ≤ 17 kg/m2.
24. 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.
18 Years
80 Years
ALL
No
Sponsors
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Shanghai Miracogen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jun Zhu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Yuqing Song, Doctor
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
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Beijing Friendship Hospital
Beijing, Beijing Municipality, China
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Hospital
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Harbin First Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Zhao Wang
Role: primary
Yu Yang, Doctor
Role: primary
Qingqing Cai, Doctor
Role: primary
Wenyu Li, Doctor
Role: primary
Yuhua Li, Doctor
Role: primary
Jun Ma, Doctor
Role: primary
Keshu Zhou, Doctor
Role: primary
Xiaojing Yan, Doctor
Role: primary
Zhuogang Liu, Doctor
Role: primary
Haiyan Yang, Doctor
Role: primary
Other Identifiers
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MRG001-001
Identifier Type: -
Identifier Source: org_study_id
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