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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRG001 | Drug | Administrated intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter: Concentration-time curve | Plot of drug concentration changing with time after drug administration. | Baseline to 90 days after the last dose of study treatment. |
| Immunogenicity | The proportion of patients with positive ADA immunogenicity results. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Program Director, Master | Contact | 86-21-61637960 | 8050 | clinicaltrials@miracogen.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jun Zhu, Doctor | Peking University Cancer Hospital & Institute | Principal Investigator |
| Yuqing Song, Doctor | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 100050 | China |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008223 | Lymphoma |
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| Baseline to 30 days after the last dose of study treatment |
| Objective Response Rate (ORR) | ORR is defined as the proportion of subjects with CR and PR. | Baseline to study completion (up to 15 months) |
| 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. | Baseline to study completion (up to 15 months) |
| Disease Control Rate (DCR) | DCR is defined as the percentage of patients who achieve CR, PR, and stable disease (SD) after treatment. | Baseline to study completion (up to 15 months) |
| 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. | Baseline to study completion (up to 15 months) |
| Overall Survival (OS) | OS is defined as the duration from the start of treatment to death of any cause. | Baseline to study completion (up to 15 months) |
| Peking University Cancer Hospital & Institute | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| Fujian Cancer Hospital | Recruiting | Fuzhou | Fujian | 350014 | China |
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| Sun Yat-sen University Cancer Hospital | Recruiting | Guangzhou | Guangdong | 510075 | China |
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| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510080 | China |
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| Zhujiang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510280 | China |
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| Harbin First Hospital | Recruiting | Harbin | Heilongjiang | 150010 | China |
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| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450003 | China |
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| The First Affiliated Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110001 | China |
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| Shengjing Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110004 | China |
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| Shanghai East Hospital | Recruiting | Shanghai | Shanghai Municipality | 200120 | China |
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| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310005 | China |
|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |