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Clinical Exploration Study of YOLT-203 in the Treatment of Type 1 Primary Hyperoxaluria (PH1)

Study acronym: PH1
StatusActive, Not Recruiting
PhaseEarly Phase 1
Started
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Record status
This record was last updated March 24, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
This study is a single-arm, open-label, single-dose, dose-escalation trial, aiming to evaluate the safety and tolerability of YOLT-203 in the Chinese population with type 1 primary hyperoxaluria (PH1); and to preliminarily assess the effect of a single dose of YOLT-203 on the plasma oxalate level.In this study, the maximum screening period of the main study is 60 days, the treatment day is Day 1 (D1), and the safety follow-up period is up to Week 52 after administration. In addition, subjects within the first dose group can voluntarily receive a second treatment with the test drug at the effective dose level. After the end of the main study, the subjects will undergo long-term followup. According to the requirements of the "Technical Guidelines for Long-Term Follow-up Clinical Studies of Gene Therapy Products (Trial)" issued by the CDE, the long-term follow-up is up to 15 years after administration. The most updated protocol is V1.2 , 22 Jan 2025
Trial Details
NCT Number NCT06892301
Lead Sponsor Guangzhou Women and Children's Medical Center
Conditions
(from sponsor)		 Type 1 Primary Hyperoxaluria
Related terms Primary hyperoxaluria type 1
Enrollment 2 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov