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A Dose Escalation and Proof-of-Concept Study of REGN5459 or REGN5458 (BCMA × CD3 Bispecific Antibodies) for Desensitization of Chronic Kidney Disease Patients in Need of Kidney Transplantation Who Are Highly Sensitized to Human Leukocyte Antigen

Trial Profile

A Dose Escalation and Proof-of-Concept Study of REGN5459 or REGN5458 (BCMA × CD3 Bispecific Antibodies) for Desensitization of Chronic Kidney Disease Patients in Need of Kidney Transplantation Who Are Highly Sensitized to Human Leukocyte Antigen

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 01 May 2025

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At a glance

  • Drugs REGN 5459 (Primary)
  • Indications Renal failure; Transplant rejection
  • Focus Adverse reactions; Proof of concept
  • Sponsors Regeneron Pharmaceuticals

Most Recent Events

  • 14 Mar 2025 Planned End Date changed from 6 Jan 2027 to 12 Dec 2026.
  • 14 Mar 2025 Planned primary completion date changed from 11 Feb 2026 to 17 Jan 2026.
  • 05 Feb 2025 Planned number of patients changed from 60 to 56.

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