MedPath

Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN)

Phase 1
Completed
Conditions
antiPLA2R Positive
Glomerulonephritis, Membranous
Interventions
Registration Number
NCT04145440
Lead Sponsor
HI-Bio, A Biogen Company
Brief Summary

This is an open-label, multicentre study to characterize the safety and efficacy of the human anti-CD38 antibody MOR202 in adult subjects with in Anti-PLA2R Antibody Positive Membranous Nephropathy (newly diagnosed/relapsed/refractory)

Detailed Description

After treatment subjects will be observed for up to 1 year.

Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
31
Inclusion Criteria
  • > 18 to < 80 years (at date of signing informed consent form [ICF]).
  • Urine protein to creatinine ratio (UPCR) of ≥ 3.000 g/g OR proteinuria ≥ 3.500 g/24 h from 24-h urine at screening
  • Active anti-PLA2R antibody positive MN in need of immunosuppressive therapy (IST) according to investigator judgement and diagnosed on the basis of a biopsy, archival biopsy acquired within 5 years prior to screening is acceptable.
  • Estimated glomerular filtration rate ≥ 50 ml/min/1.73m² or ≥ 30 and <50 ml/min/1.73m², and interstitial fibrosis and tubular atrophy score of less than 25% on a renal biopsy obtained within the last 6 months prior to start of screening.
  • Not in spontaneous remission despite proper treatment with ACEIs, ARBs (sufficient dose and treatment duration) as per clinical practice and scientific guidelines. If the subject is intolerant to an ACEI or ARB, the reason must be documented and approval obtained prior to enrolment.
  • Systolic blood pressure BP ≤150 mmHg and diastolic BP ≤100 mmHg after 5 minutes of rest
  • Vaccinated against Pneumococcus within the last 5 years prior to date of signing informed consent (subjects may be vaccinated during screening to meet this criterion; interval to first dose of MOR202 must be at least 14 days).
  • Cohort 1 comprises newly diagnosed or relapsed subjects: Serum anti-PLA2R antibodies ≥50.0 RU/mL
  • Cohort 2 comprises therapy refractory subjects: a Subject did not achieve immunological remission after prior IST(s) as documented by the investigator AND b Subject is without promising standard therapeutic options as documented by the investigator (i.e. investigator expects efficacy or safety issues with remaining IST options) AND c Serum anti-PLA2R antibodies ≥ 20.0 RU/mL measured at screening

Note: France will only enroll patients in Cohort 2.

Key

Exclusion Criteria
  • Hemoglobin < 80 g/L.
  • Thrombocytopenia: Platelets < 100.0 x 109/L.
  • Neutropenia: Neutrophils < 1.5 x 109/L.
  • Leukopenia: Leukocytes < 3.0 x 109/L.
  • Hypogammaglobulinemia: Serum immunoglobulins ≤ 4.0 g/L.

Subjects may receive supportive therapies to meet the above criteria

  • B-cells < 5 x 106/L.
  • Secondary cause of MN (e.g. Systemic lupus erythematosus, medications, malignancies)
  • Concomitant renal disease other than MN (e.g., diabetic renal disease, lupus nephritis, IgA nephropathy).

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Cohort 2 (refractory participants)MOR202Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
Cohort 1 (newly diagnosed or relapsed participants)MOR202Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
Primary Outcome Measures
NameTimeMethod
Number of Participants With Adverse EventsWeek 1 to Week 24

An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Percentage of Participants With Adverse EventsWeek 1 to Week 24

An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Secondary Outcome Measures
NameTimeMethod
Percentage of Participants Tested Positive for Anti-felzartamab AntibodiesBaseline; Up to 52 weeks
Felzartamab Serum Concentrations After Multiple Intravenous AdministrationsPre Dose and Post Dose on Cycle 1 Day 1 (C1D1), C1D8, C1D15, C1D22, C2D1, C3D1, C4D1, C5D1, C6D1, End of Treatment (week 24), Follow-up visit (week 38), End of Study (up to 52 weeks)
Number of Participants With AEs During the Follow-up PeriodWeek 25 to Week 52

An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Antibody Titers of Participants Tested Positive for Anti-felzartamab AntibodiesBaseline; Up to 52 weeks
Best Immunological Response Rate (BIRR)Up to 52 weeks

The BIRR was defined as the percentage of participants with a best immunological response of stringent immunological complete response (sICR), immunological complete response (ICR), or immunological partial response (IPR) prior to the start of prohibited treatment or progression, based on reduction of serum anti-PLA2R antibody titer.

Number of Participants Tested Positive for Anti-felzartamab AntibodiesBaseline; Up to 52 weeks
Percentage of Participants With AEs During the Follow-up PeriodWeek 25 to Week 52

An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Trial Locations

Locations (45)

North America Research Institute

🇺🇸

Azusa, California, United States

UCSF Medical Center

🇺🇸

San Francisco, California, United States

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

🇺🇸

Torrance, California, United States

University of Miami Division of Nephrology & Hypertension

🇺🇸

Miami, Florida, United States

GA Nephrology Associates

🇺🇸

Lawrenceville, Georgia, United States

Northwest Louisiana Nephrology Research

🇺🇸

Shreveport, Louisiana, United States

Kidney Care and Transplant Services of New England, PC

🇺🇸

Springfield, Massachusetts, United States

Mayo Clinic

🇺🇸

Rochester, Minnesota, United States

The Ohio State University Wexner Medical Center

🇺🇸

Columbus, Ohio, United States

MedResearch, Inc

🇺🇸

El Paso, Texas, United States

Scroll for more (35 remaining)
North America Research Institute
🇺🇸Azusa, California, United States

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.