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Clinical Trials in China / NCT06685536
Enrolling by invitation Observational

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

NCT06685536 · tracked via the Priya Life Science China tracker
Sponsor
CorrectSequence Therapeutics Co., Ltd
Phase
Observational
Started
2025-01-18
Last updated
2026-02-10

Condition(s) studied

Beta-Thalassemia

Investigational drug(s) / intervention(s)

Safety and efficacy assessments

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

Study 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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
35 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Frequency and severity of SAEs and CS-101 related AES as assessed by CTCAE v5.0 — Through 15 years post CS-101 infusion
    CommonTerminology Criteria for Adverse Events#CTCAE#has 5 levels of AE determination, increasing in severity as the level increases
  • New malignancies and hematologic disorders — Through 15 years post CS-101 infusion
    Based on ICD-11
  • Occurrence of all-cause death — Through 15 years post CS-101 infusion
  • Occurrence of achieving transfusion independence for at least 12 consecutive months — Through 15 years post CS-101 infusion

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Guangxi Medical University Nanning Guangxi

More CorrectSequence Therapeutics Co., Ltd trials in China

CS-121 APOC3 Base Editing in FCS Recruiting
CS-206 in Patients With Sickle Cell Disease Recruiting
CS-101 in Patients With β-thalassemia Enrolling by invitation
CS-121 APOC3 Base Editing in Severe Hypertriglyceridemia Starting soon
A Phase 2 Safety and Efficacy Study Evaluating CS-101 in Participants With β-Thalassemia Major Starting soon

Other trials for the same condition

A Multiple Ascending Dose Study of 9MW3011 in Patients With Non-transfusion-dependent β-thalassemia Recruiting
Gene Therapy of Beta Thalassemia Using a Self-inactivating Lentiviral Vector Starting soon
A Long-term Follow-up Study in Participants Who Received CS-101 Recruiting
A Study to Evaluate Luspatercept (ACE-536) in Chinese Participants Who Require Regular Red Blood Cell Transfusions Due to Beta (β)-Thalassemia. Active, not recruiting
Safety and Efficacy Evaluation of BRL-101 in Subjects With Transfusion-Dependent β-Thalassemia Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06685536 on ClinicalTrials.gov ↗ ← All trials in China