This is a study to evaluate the long-term safety and efficacy of CS-101 in participants who received CS-101 in study CS -101-01 (NCT06291961),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 -101-01 (NCT06291961). Subjects in the CS-101-01 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) follow up visit after treatment with CS-101 Injection.
Study Type
OBSERVATIONAL
Enrollment
8
The First Affiliated Hospital of Guangxi Medical University
Nanning, China
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
Time frame: Through 15 years post CS-101 infusion
Occurrence of all-cause death
Time frame: Through 15 years post CS-101 infusion
Occurrence of achieving transfusion independence for at least 12 consecutive months
Time frame: Through 15 years post CS-101 infusion
Change in fetal hemoglobin(HbF) concentration over time
Time frame: Through 15 years post CS-101 infusion
Change in total hemoglobin(Hb) concentration over time
Time frame: Through 15 years post CS-101 infusion
Chimerism level in Peripheral blood Proportion of alleles with intended genetic modification in
Time frame: Through 15 years post CS-101 infusion
Chimerism level in bone marrow Proportion of alleles with intended genetic modification in
Time frame: Through 15 years post CS-101 infusion
Change in F-Cell concentration over time
Time frame: Through 15 years post CS-101 infusion
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