Open-Label Phase 1/2 Study of Daratumumab-Based Desensitization Before Kidney Transplantation.

ABSTRACT:

Introduction

The safety and benefit of the anti-CD38 monoclonal antibody daratumumab, which induces lysis of antibody-producing plasma cells in sensitized patients prior to kidney transplantation, remain to be determined.

Methods

A 2-phase (1 and 2), monocentric open-label study was conducted to evaluate the month 6 (M6) safety and efficacy of daratumumab in kidney transplant candidates with calculated panel reactive antibody (cPRA) > 95%. In the first (safety) phase, we used 4-weekly escalating doses of daratumumab. Phase 2 tested desensitization with 8 weekly infusions of 16 mg/kg daratumumab. cPRA 10,000 was calculated considering only human leukocyte antigen (HLA) antibodies with mean fluorescence intensity (MFI) of > 10,000.

Results

Nine patients were enrolled in

SUBMITTER: Pilon C 

PROVIDER: S-EPMC11551132 | biostudies-literature | 2024 Nov

REPOSITORIES: biostudies-literature