MorphoSys – Anti-PLA2R (aMN)
MorphoSys is a company specialized in developing therapeutic antibodies. Recently a clinical study has been started for the indication of Anti-PLA2R Antibody Positive Membranous Nephropathy (aMN).
This is a Phase Ib/IIa, open-label, multicentre study to characterize the safety and efficacy of the human anti-CD38 antibody MOR202 in adult subjects with Anti-PLA2R Antibody Positive Membranous Nephropathy (newly diagnosed/relapsed/refractory).
You can find the key inclusion and exclusion criteria for the study below. If you are interested in participation or think you might have eligible patients for this study, you are welcome to contact a study site close to you. You will find a list of participating centers and contact details of MorphoSys (sponsor) on the website of www.clinicaltrials.gov with the study identifier: NCT04145440 or click here.
- 18 years to 80 years of age (Adult, Older Adult)
- Urine protein to creatinine ratio of ≥3.0 g/g (as measured from a 24 hour urine collection)
- Active anti-PLA2R antibody positive MN in need for 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.
- On supportive treatment with an Angiotensin Converting Enzyme Inhibitor or an Angiotensin II Receptor Blocker for at least 4 weeks prior to Screening, having reached a stable dose.
- Systolic BP ≤150 mmHg and diastolic BP ≤100 mmHg
- Vaccinated against Pneumococcus within the last 3 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 1a (newly diagnosed patients): Serum anti-PLA2R antibodies ≥150.0 Response Units (RU)/mL determined at screening.
- Cohort 1b, relapse subjects: must have had complete immunological and/or clinical remission according to judgement of the investigator and serum anti-PLA2R antibodies ≥50.0 RU/mL determined at screening
Cohort 2: Failure of previous therapy, i.e. subject never achieved a complete immunological and/or clinical remission according to judgement of the investigator during or after completion of a recognized IST containing cyclosporine A, tacrolimus, mycophenolate-mofetil, ACTH or alkylating agents (e.g. cyclophosphamide), or rituximab. Serum anti-PLA2R antibodies ≥20.0 RU/mL determined at screening
- Hemoglobin <90 g/L
- Thrombocytopenia: Platelets <100.0×109/L
- Neutropenia: Neutrophils <1.5×109/L
- Leukopenia: Leukocytes <3.0×109/L
- Hypogammaglobulinemia: Serum immunoglobulins ≤5.0 g/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)
What is the study drug: MOR202?
MOR202 is an investigational human monoclonal HuCAL antibody directed against CD38.
The cell surface antigen CD38 is a molecule highly expressed on antibody-producing plasma cells and plasmablasts. Binding of MOR202 is thought to induce depletion of such cells. Since depletion of antibody-producing cells subsequently should lead to a decrease in blood antibody amount, treatment with MOR202 is being studied in autoantibody-mediated immune diseases with a correlation of autoantibody titers.