NCT06685536

A Long-term Follow-up Study in Participants Who Received CS-101

A Long-term Follow-up Study Evaluating the Safety and Efficacy of Subjects With β-thalassemia Treated With Base-edited Autologous Hematopoietic Stem Cell (CS-101) Transplantation

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 5 (estimated)
• Sponsor: CorrectSequence Therapeutics Co., Ltd · Industry
• Sex: All
• Age: 6 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

This is a study to evaluate the long-term safety and efficacy of CS-101 in participants who received CS-101 in study CS -101-06 (NCT06024876),No investigational drug product will be administered in the study.

Detailed description

This is a study to evaluate the long-term safety and efficacy of CS-101 in participants who received CS-101 in study CS -101-06 (NCT06024876). Subjects in the CS-101-06 study will be entered into long-term follow-up of this study up to 15 years post-infusion at the completion of the last (12-month) followup visit after treatment with CS-101 Injection.

Conditions

• Beta-Thalassemia

Interventions

Type	Name	Description
OTHER	Safety and efficacy assessments	Safety evaluations,disease-specific assessments,and assessments to monitor for long-term complications of autologous transplant

Timeline

• Start date: 2025-01-18
• Primary completion: 2039-07-01
• Completion: 2039-07-01
• First posted: 2024-11-12
• Last updated: 2026-02-10

Locations

1 site across 1 country: China