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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety and efficacy assessments | Safety evaluations,disease-specific assessments,and assessments to monitor for long-term complications of autologous transplant |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through 15 years post CS-101 infusion |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fetal hemoglobin(HbF) concentration over time | Through 15 years post CS-101 infusion | |
| Change in total hemoglobin(Hb) concentration over time | Through 15 years post CS-101 infusion | |
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Inclusion Criteria:
Exclusion Criteria:
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Subject with β-thalassemia treated with CS-101 infusion in CS-101-01 study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangxi Medical University | Nanning | China |
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| ID | Term |
|---|---|
| D017086 | beta-Thalassemia |
| ID | Term |
|---|---|
| D013789 | Thalassemia |
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
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| Chimerism level in Peripheral blood Proportion of alleles with intended genetic modification in |
| Through 15 years post CS-101 infusion |
| Chimerism level in bone marrow Proportion of alleles with intended genetic modification in | Through 15 years post CS-101 infusion |
| Change in F-Cell concentration over time | Through 15 years post CS-101 infusion |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |