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

N/AEnrolling By InvitationNCT06685536

CorrectSequence Therapeutics Co., Ltd5 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Beta-Thalassemia

Interventions

Safety and efficacy assessmentsOTHER

Safety evaluations,disease-specific assessments,and assessments to monitor for long-term complications of autologous transplant

Eligibility

Sex: ALLMin age: 6 YearsMax age: 35 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants (or his or her legally appointed and authorized representative or guardian) must sign and date informed consent form (ICF) and, where applicable, an assent form * Participants must have received CS-101 infusion in last study Exclusion Criteria: * There are no exclusion criteria

Locations (1)

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Outcomes

Primary Outcomes

Frequency and severity of SAEs and CS-101 related AES as assessed by CTCAE v5.0

CommonTerminology Criteria for Adverse Events#CTCAE#has 5 levels of AE determination, increasing in severity as the level increases