Antibody Information
General Information of This Antibody
| Antibody ID | ANI0OAIXG |
|||||
|---|---|---|---|---|---|---|
| Antibody Name | Chimeric anti-CD20 mAb |
|||||
| Antibody Type | Monoclonal antibody (mAb) |
|||||
| Antibody Subtype | Chimeric IgG1-kappa |
|||||
| Antigen Name | B-lymphocyte antigen CD20 (MS4A1) |
Antigen Info | ||||
| Click to Show/Hide the Sequence Information of This Antibody | ||||||
Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
MRG001 [Phase 2 (discontinued)]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
23.81
33.33 66.70 % |
|||
| Patients Enrolled |
CD20-positive relapsed or refractory (R/R) B-cell non Hodgkin lymphoma (NHL).
|
||||
| Administration Dosage |
Six dose levels ranging from 0.15 to 2.50 mg/kg, intravenously once every 3 weeks (Q3W) for a maximum of 6 treatment cycles.
|
||||
| Related Clinical Trial | |||||
| NCT Number | NCT05155839 | Clinical Status | Phase 1 | ||
| Clinical Description |
An open-label, multicenter, first-in-human, phase 1 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).
|
||||
| Primary Endpoint |
Rp2D=1.80 mg/kg.
|
||||
| Other Endpoint |
Among 21 pts who had at least one tumor assessment, ORR=23.81% , PR rate=19.05% (N=4),CR rate=4.76% (N=1).
|
||||
| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT05844527 | Clinical Status | Phase 2 | ||
| Clinical Description |
Safety and efficacy of MRG-001 in wound healing in pre-abdominoplasty surgical excisions and scar appearance in subjects undergoing abdominoplasty.
|
||||
| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Eligible patients (18-80 years) had relapsed/refractory B-cell NHL post-anti-CD20 therapy, ≥1 measurable lesion (Lugano 2014), ECOG 0-1, adequate organ function, and resolved prior toxicities (≤Grade 1). Exclusions: active HBV/HCV/HIV infection, uncontrolled infections/cardiovascular/pulmonary diseases, recent CAR-T/transplant/vaccines, concomitant CYP3A4 modulators, pregnancy/lactation, or conditions increasing study risk per investigator judgment. Phase Ia/Ib had specific hepatitis criteria.
Click to Show/Hide
|
||||
| Administration Dosage |
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).
|
||||
| Related Clinical Trial | |||||
| NCT Number | NCT05155839 | Clinical Status | PHASE1 | ||
| Clinical Description |
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)
|
||||
| Primary Endpoint |
This study evaluates safety and dosing through adverse events (AEs) recorded from baseline to 90 days post-treatment, maximum tolerated dose (MTD) defined by ≤1/6 patients experiencing dose-limiting toxicities (DLTs) in Cycle 1, and the establishment of a recommended Phase II dose (RP2D) for MRG001.
|
||||
| Other Endpoint |
Secondary assessments include pharmacokinetics (concentration-time curves), immunogenicity (ADA positivity), and efficacy measures: objective response rate (ORR), duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS)-tracked for up to 15 months from baseline.
|
||||
| Experiment 4 Reporting the Activity Date of This ADC | [4] | ||||
| Patients Enrolled |
Eligible adults (≥21 years) with recent-onset jaundice and heavy alcohol use (≥40g/day females, ≥60g/day males) must meet AH biochemical criteria (bilirubin >3mg/dL, AST 50-400 IU/L, MELD 21-30). Exclusions: concurrent liver diseases (viral/autoimmune), active infections, uncontrolled GI bleeding, severe organ dysfunction (EF <20%, platelets <30K/mm <sup>3</sup>, hepatic encephalopathy ≥3), malignancies (<5 years), HIV/TB co-infection, transplant recipients, or hypersensitivity to MRG-001 components. Women must use contraception.
Click to Show/Hide
|
||||
| Related Clinical Trial | |||||
| NCT Number | NCT06307522 | Clinical Status | PHASE2 | ||
| Clinical Description |
An Open-Label, Dose-Escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of MRG-001 in Patients With Alcoholic Hepatitis
|
||||
| Primary Endpoint |
The study evaluates MRG-001's safety and tolerability in alcoholic hepatitis (AH) patients by monitoring treatment-emergent adverse events (TEAEs) over 28 days, with SUSAR reporting as a key safety measure.
|
||||
| Other Endpoint |
Pharmacokinetic analysis focuses on MRG-001's PK profile (trough levels of plerixafor/tacrolimus), while pharmacodynamic effects are assessed via flow cytometry to track CD34+ stem cell mobilization vs. baseline during the 28-day period.
|
||||
| Experiment 5 Reporting the Activity Date of This ADC | [5] | ||||
| Patients Enrolled |
Eligible patients (18-75 years) must have ALS (El Escorial criteria, symptom onset ≤48 months), ≥50% predicted vital capacity, and stable/no use of riluzole/edaravone/Relyvrio. Exclusions: organ dysfunction (e.g., EF <20%, platelets <30K/mm <sup>3</sup>, CrCl <50 mL/min), active cancer (exceptions apply), psychiatric/cognitive impairment, prior ALS gene therapy, HIV, transplants, immunosuppressants (except steroids), pregnancy, or MRG-001 hypersensitivity.
Click to Show/Hide
|
||||
| Administration Dosage |
MRG-001 will be subcutaneously administered at 0.01 mL/kg 3 times per week every other day for two weeks per month (Day 0, 2, 4, 7, 9, 11). This cycle will be repeated 3 months in total.
|
||||
| Related Clinical Trial | |||||
| NCT Number | NCT06315608 | Clinical Status | PHASE2 | ||
| Clinical Description |
An Open-Label, Proof of Concept Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of MRG-001 in Patients With Amyotrophic Lateral Sclerosis
|
||||
| Primary Endpoint |
The study evaluates the safety of MRG-001 in ALS patients over a 3-month period by monitoring treatment-emergent adverse events, with absence of serious adverse events (SAEs) as the primary safety endpoint.
|
||||
| Other Endpoint |
Key secondary endpoints include stem cell mobilization (CD34+ count change at 24h), regulatory T-cell response (FOXP3+ count change at 24h), and disease progression (ALSFRS-R score at 0/1/2/3 months-higher scores indicate better function; positive/negative changes reflect reversal/worsening of ALS).
|
||||
| Experiment 6 Reporting the Activity Date of This ADC | [6] | ||||
| Patients Enrolled |
Eligible participants (18-55 years) are healthy non-smokers (BMI 25-35) undergoing elective abdominoplasty. Exclusions: recent investigational drug use, diabetes (HbA1C >5.7%), prior abdominal procedures, poor wound healing, collagen disorders, immunomodulatory therapy, pregnancy/breastfeeding, substance abuse, MRG-001 hypersensitivity, or situations compromising protocol adherence. Female participants must use contraception.
Click to Show/Hide
|
||||
| Administration Dosage |
MRG-001 will be administered subcutaneously at 0.01 mL/kg bodyweight 3 times per week for 3 weeks.
|
||||
| Related Clinical Trial | |||||
| NCT Number | NCT05844527 | Clinical Status | PHASE2 | ||
| Clinical Description |
Safety and Efficacy of MRG-001 in Wound Healing and Scar Appearance in Pre-Abdominoplasty Surgical Excisions
|
||||
| Primary Endpoint |
The study assesses the preliminary effectiveness of MRG-001 on scar tensile strength, comparing Newton force measurements between MRG-001 and saline treatments during Weeks -6 to 0.
|
||||
| Other Endpoint |
Safety, pharmacokinetics (Cmax, trough levels, clearance, t½), and pharmacodynamics (stem/immune cell presence in blood/tissue) of MRG-001 are evaluated versus placebo. Additional endpoints include time to wound re-epithelization (photographic assessment), scar appearance (modified POSAS), VAS pain scores, infection rates, and histological analysis of CD133+/CD34+/FOXP3+/macrophage cell populations in scars (Weeks -6 to 0).
Click to Show/Hide
|
||||
References