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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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)

More CorrectSequence Therapeutics Co., Ltd trials in China

Other trials for the same condition