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A Clinical Exploratory Study of YOLT-204 in the Treatment of Hemoglobinopathies

NCT07774351 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-19

No results posted yet for this study

Summary

This is a single-arm, open-label, dose-escalation study designed to enroll approximately 5-30 patients with TDT or SCD. The objectives are to evaluate the safety and tolerability in patients following intravenous administration of YOLT-204 and to preliminarily assess its effect on fetal hemoglobin levels in plasma.

In this study, the maximum screening period of the main study is 60 days, the treatment day is Day 0 (D0), and the safety follow-up period is up to Week 52 after administration.

Conditions

  • Hemoglobinopathies

Interventions

GENETIC

YOLT-204

YOLT-204 treatment on Day0

Sponsors & Collaborators

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-04-01
Completion
2028-04-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07774351 on ClinicalTrials.gov