Long Term Follow-up Observational Study in Patients Treated with Gene-Modified T-Cell Therapy

Not yet recruiting

• Conditions: Relapsed or Refractory Multiple Myeloma

• Registration Number: NCT06825845
• Lead Sponsor: CARsgen Therapeutics Co., Ltd.

Brief Summary

This is a prospective long-term follow-up (LTFU) study to evaluate the long-term safety and survival benefit for patients who received at least one of CARsgen's GM T cell product in a clinical trial or as a commercially available product. In this study, patients will be followed for up to 15 years after last GM T-cell infusion for the evaluation of delayed adverse events (AEs), vector persistence, potential risk for integration, and survival time due to GM T-cell exposure.

Detailed Description

As recommended by Health Authorities guidelines for human gene therapy products containing an integrated transgene, during the LTFU for 15 years after infusion, the information of the enrolled patients will be collected, including medical history, physical and laboratory-related examination data, AEs, survival information, etc. AEs recorded will include new malignancy, new or exacerbation infection, new or exacerbation neurological disease, new or exacerbation autoimmune disease etc. Samples will be obtained according to the schedule of activities, and laboratory tests will be conducted or preserved for future use.

All participants are recommended to be followed at least every six months for the first 5 years, and annually from the 6th year until at least 15 years or until informed consent withdrawal, loss to follow-up, or death, whichever occurs first.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-02-08
• Study First Submitted QC: 2025-02-08
• Last Update Submitted: 2025-02-08
• Study First Posted: 2025-02-13
• Last Update Posted: 2025-02-13
• Study Start: 2025-03-31
• Primary Completion: 2039-12-31
• Study Completion: 2040-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• 1. All patients who have received at least one GM T-cell infusion in the parent clinical study or in the post-approval setting.

2. Patients must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. For patients incapable of providing consent, the signed ICF of their legally accepted guardians must be obtained.

Exclusion Criteria

• There are no specific exclusion criteria for this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the risk of delayed AEs following exposure to GM T cells	15 years