By InvitationNot Applicable

A Follow-up Study to Evaluate the Long-term Safety and Efficacy in Participants Who Received CS-101 Injection

China8 participantsStarted 2025-05-15

Plain-language 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 -101-01 (NCT06291961),No investigational drug product will be administered in the study.

Who can participate

Age range12 Years – 35 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants must have received CS-101 infusion in CS-101-01 study * 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 Exclusion Criteria: * There are no exclusion criteria

What they're measuring

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

Timeframe: Through 15 years post CS-101 infusion

Occurrence of all-cause death

Timeframe: Through 15 years post CS-101 infusion

Occurrence of achieving transfusion independence for at least 12 consecutive months

Timeframe: Through 15 years post CS-101 infusion

Trial details

NCT IDNCT06717932

SponsorCorrectSequence Therapeutics Co., Ltd

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2039-11

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