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A Phase 1/2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of IMPT-514 in Participants With Active, Refractory Lupus Nephritis and Systemic Lupus Erythematosus

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Trial Profile

A Phase 1/2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of IMPT-514 in Participants With Active, Refractory Lupus Nephritis and Systemic Lupus Erythematosus

Status: Withdrawn prior to enrolment
Phase of Trial: Phase I/II

Latest Information Update: 13 Feb 2025

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At a glance

  • Drugs IMPT-514 (Primary) ; Cyclophosphamide; Fludarabine
  • Indications Lupus nephritis; Systemic lupus erythematosus
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors ImmPACT Bio; Lyell Immunopharma

Most Recent Events

  • 24 Jan 2025 Status changed from recruiting to withdrawn prior to enrolment, as per sponsor's decision.
  • 29 Feb 2024 Status changed from not yet recruiting to recruiting.
  • 28 Feb 2024 According to an ImmPACT Bio media release, the company has been awarded an $8 million grant from the California Institute for Regenerative Medicine (CIRM) to ImmPACT Bio's ongoing Phase 1b/2 study evaluating IMPT-514 for the treatment of refractory lupus nephritis (LN) and systemic lupus erythematosus (SLE). Company expect initial efficacy and safety data from this Phase 1b/2 dose escalation trial in the second half of 2024.

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