Evidence map›Paper›PMID 39291206›Full record

ArticleKidney international reports2024

Phase 1b/2a Study Assessing the Safety and Efficacy of Felzartamab in Anti-Phospholipase A2 Receptor Autoantibody-Positive Primary Membranous Nephropathy.

Brad H Rovin, Pierre M Ronco, Jack F M Wetzels, Sharon G Adler, Isabelle Ayoub, Philippe Zaoui, Seung Hyeok Han, Jaideep S Dudani, Houston N Gilbert, Uptal D Patel and 6 more

Registry-linked trialAbstract read
In one paragraph

Article in Kidney international reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04145440 (A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy), which is not on this map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04145440 phase1 / phase2completednot on this map

A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (aMN)

TypeinterventionalSponsorHI-Bio, A Biogen CompanyRan2019 to 2022Enrolled31ConditionsGlomerulonephritis, Membranous, antiPLA2R PositiveArmsMOR202
3 · Its place in the literature

Who cites it

18 citing papers in PubMed.

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  2. Review
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  17. Targeting CD38 in Antibody-Mediated Rejection.Transplant international : official journal of the European Society for Organ Transplantation · 2025
    Review
  18. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Brad H RovinDepartment of Medicine and Division of Nephrology, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
Pierre M RoncoSorbonne Université and INSERM UMRS 1155, Paris France.
Jack F M WetzelsDepartment of Nephrology, Radboud University Medical Center, Nijmegen, The Netherlands.
Sharon G AdlerLundquist Research Institute at Harbor UCLA, Torrance, California, USA.
Isabelle AyoubDepartment of Medicine and Division of Nephrology, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
Philippe ZaouiCentre Hospitalier Universitaire Grenoble Alpes, Grenoble, France.
Seung Hyeok HanYonsei University College of Medicine, Seoul, South Korea.
Jaideep S DudaniHuman Immunology Biosciences, Inc., South San Francisco, California, USA.
Houston N GilbertHuman Immunology Biosciences, Inc., South San Francisco, California, USA.
Uptal D PatelHuman Immunology Biosciences, Inc., South San Francisco, California, USA.
Paul T ManserHuman Immunology Biosciences, Inc., South San Francisco, California, USA.
Julia Jauch-LembachMorphoSys AG, Planegg, Germany.
Nicola FaulhaberMorphoSys AG, Planegg, Germany.
Rainer BoxhammerMorphoSys AG, Planegg, Germany.
Stefan HärtleMorphoSys AG, Planegg, Germany.
Ben SprangersKatholieke Universiteit Leuven, Leuven, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Primary membranous nephropathy (PMN) is most often caused by autoantibodies to phospholipase A2 receptor (PLA2R). M-PLACE (NCT04145440) is an open-label, phase 1b/2a study that assessed the safety and efficacy of the fully human anti-CD38 monoclonal antibody felzartamab in high-risk anti-PLA2R+ PMN. Methods: Patients with newly diagnosed or relapsed PMN (cohort 1 [C1]; Results: A total of 31 patients were enrolled and received felzartamab. Twenty-seven patients (87.1%) had TEAEs, including infusion-related reactions (IRRs) (29.0%), hypogammaglobulinemia (25.8%), peripheral edema (19.4%), and nausea (16.1%). Five patients (16.1%) had serious TEAEs that all resolved. Immunologic response (anti-PLA2R titer reduction ≥50%) was achieved by 20 of 26 efficacy-evaluable patients (76.9%) (C1, 13/15 [86.7%]; C2, 7/11 [63.6%]). Anti-PLA2R titer reductions were rapid (week 1 response, 44.0%; response 7 months after last felzartamab dose [end of study, EOS], 53.8%). Partial proteinuria remission (urine protein-to-creatinine ratio [UPCR] reduction ≥50%, UPCR <3.0 g/g, and stable estimated glomerular filtration rate [eGFR]) was achieved by 9 of 26 patients (34.6%) (C1, 7/15 [46.7%]; C2, 2/11 [18.2%]) before or at EOS (median follow-up, 366 days). Serum albumin increased from baseline to EOS in 20 of 26 patients (76.9%) (C1, 12/15 [80.0%]; C2, 8/11 [72.7%]). Conclusion: In this population with high-risk anti-PLA2R+ PMN, felzartamab was tolerated and resulted in rapid partial and complete immunologic responses and partial improvements in proteinuria and serum albumin in some patients.

Indexed as

clinical trialfelzartamabMOR202phase 2phospholipase A2 receptorprimary membranous nephropathy

Identifiers

PMID39291206
PMCPMC11403052

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.