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YOLT-204 in Patients With Hemoglobinopathies

StatusNot Yet Recruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
This is a single-arm, open-label, single-dose, dose-escalation trial that plans to enrol 3-18 patients with transfusion-dependent β-thalassaemia (TDT) or sickle-cell disease (SCD). Its primary aims are to evaluate the safety and tolerability of a single administration of YOLT-204 and to obtain preliminary data on its effect on plasma fetal-haemoglobin levels. The main-study screening period may last up to 60 days; the treatment day is Day 0 (D0). Safety follow-up continues through Week 52 post-dose. After completion of the main study, participants will enter long-term follow-up extending to 15 years post-dose.
Trial Details
NCT Number NCT07190001
Lead Sponsor Guangzhou Women and Children's Medical Center
Conditions
(from sponsor)		 Hemoglobinopathies (Transfusion-dependent β-thalassemia and Sickle Cell Disease)
Related terms Anemia, Sickle Cell, Hemoglobinopathies
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov