Long Term Follow-up Observational Study in Patients Treated with Gene-Modified T-Cell Therapy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCARsgen Therapeutics Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
There are no specific exclusion criteria for this study.
Trial population
Before any study procedure, informed consent must be signed by the participants, or by the participant's legal guardian for patients with no full civil capacity
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Zevorcabtagene Autoleucel
DrugNon-intervention
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
To assess the risk of delayed AEs following exposure to GM T cells
Time frame
15 yearsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: