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

NCT05155839 | Unknown Phase 1

• 1 other identifier: MRG001-001
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 12

Brief 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 confirmed RP2D. The safety, tolerability, pharmacokinetic (PK) and immunogenicity of MRG001 will be evaluated in both parts.

Conditions

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

Keywords

MRG001; Antibody Drug Conjugate (ADC); CD20; Non-Hodgkin lymphoma (NHL)

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• Recommended Phase II Dose (RP2D)

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

  Baseline to study completion (up to 15 months).

Secondary Outcomes (7)

• PK parameter: Concentration-time curve

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

• Immunogenicity

  Baseline to 30 days after the last dose of study treatment

• Objective Response Rate (ORR)

  Baseline to study completion (up to 15 months)

• Duration of Response (DoR)

  Baseline to study completion (up to 15 months)

• Disease Control Rate (DCR)

  Baseline to study completion (up to 15 months)

Study Arms (1)

MRG001

EXPERIMENTAL

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).

Drug: MRG001

Interventions

MRG001 DRUG

Administrated intravenously

MRG001

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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%.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shanghai Miracogen Inc.: lead

Study Sites (12)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100142, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

RECRUITING

Sun Yat-sen University Cancer Hospital

Guangzhou, Guangdong, 510075, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

RECRUITING

Harbin First Hospital

Harbin, Heilongjiang, 150010, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310005, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jun Zhu, Doctor

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

• Yuqing Song, Doctor

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Program Director, Master

CONTACT

86-21-61637960; clinicaltrials@miracogen.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 14, 2021
• Study Start: June 25, 2019
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (12)