NCT06825845Not yet recruiting
Long Term Follow-up Observational Study in Patients Treated with Gene-Modified T-Cell Therapy
Source: ClinicalTrials.gov · Last updated 13 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 1500 (estimated)
- First submitted
- 8 Feb 2025
- Start date
- 31 Mar 2025
- Primary completion date
- 31 Dec 2039
- Lead sponsor
- CARsgen Therapeutics Co., Ltd.
- Diseases
- Multiple myeloma, Childhood cancers
- NCT number
- NCT06825845
What you commit to
- Study type: Observational
- Planned participants: 1500
- From 31 Mar 2025 to the primary completion date, 31 Dec 2039
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- There are no specific exclusion criteria for this study.
Who the study is looking for
- \- 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.
Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.