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

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

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-18

Study Completion Date

2039-07-31

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 -101-06 (NCT06024876),No investigational drug product will be administered in the study.

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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 -101-06 (NCT06024876). Subjects in the CS-101-06 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) followup 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

Interventions

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Safety and efficacy assessments

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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
* Participants must have received CS-101 infusion in last study

Minimum Eligible Age

6 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No