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A Phase 1b Open-Label, Multicenter, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacodynamic Effects of a Single Dose of PBFT02 Delivered Into the ICM of Adults With FTD and Mutations in the GRN or C9ORF72 Genes

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Trial Profile

A Phase 1b Open-Label, Multicenter, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacodynamic Effects of a Single Dose of PBFT02 Delivered Into the ICM of Adults With FTD and Mutations in the GRN or C9ORF72 Genes

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 30 Jun 2025

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At a glance

  • Drugs PBFT 02 (Primary)
  • Indications Frontotemporal dementia
  • Focus Adverse reactions; Pharmacodynamics; Pharmacogenomic; Therapeutic Use
  • Acronyms upliFT-D
  • Sponsors Passage Bio

Most Recent Events

  • 23 Jun 2025 According to a Passage Bio media release, In addition, the company intends to amend study inclusion criteria to allow for enrollment of patients who are prodromal or have mild cognitive impairment and exclude patients who are more severely progressed. The company plans to submit the amended protocol to health authorities in early July. Upon review and acceptance of the amended protocol, the company plans to begin enrollment in Cohort 3 (FTD-GRN) and Cohort 4 (FTD-C9orf72).
  • 23 Jun 2025 According to a Passage Bio media release, Patient 9 will complete Cohort 2, and subsequent patients will be treated as part of Cohort 3, which is now expected to consist of five to 10 patients.
  • 23 Jun 2025 According to a Passage Bio media release, company plans to amend the upliFT-D clinical trial protocol to introduce a short course of low dose prophylactic anticoagulation, a decision supported by study investigators and the Independent Data Monitoring Committee (IDMC). The IDMC and U.S. Food and Drug Administration agreed that dosing of Patient 9, who previously enrolled in the study, may proceed with additional safety monitoring in place prior to amendment completion.

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