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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-31

Study Completion Date

2039-11-30

Brief Summary

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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.

Detailed Description

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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). 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.

Conditions

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Beta-Thalassemia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Safety and efficacy assessments

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital of Guangxi Medical University

Nanning, , China

Site Status

Countries

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China

Other Identifiers

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CS-101-05

Identifier Type: -

Identifier Source: org_study_id