This study will evaluate the long-term safety of ARD103 cellular therapies
The participant has R/R AML or MDS and has previously received ARD103 CAR-T cell therapies in the parent study.
The participant is able to understand and comply with protocol-required study procedures and has provided a written informed consent document.
There are no specific exclusion criteria for this study
The study population will comprise participants with R/R AML or MDS treated with ARD103. All subjects with AML or MDS who are enrolled in a parent study and were received ARD103 CAR-T infusion will be asked to participate in this long-term follow-up (LTFU) study.
Cohort
Prospective
Non interventional study
Other interventionNon Intervention, an observation LTFU study
The incidence and duration of AEs, SAEs, and AESIs related to ARD103 treatment.
The number and percentages of participants experiencing TEAEs will be tabulated. Serious TEAEs will be summarized and AESIs will be summarized.
The long-term efficacy of ARD103 in participants with R/R AML or MDS
Overall survival (OS): the time from the infusion of ARD103 CAR-T in the parent study until death for any cause. Duration of Response (DOR): the time from the first recorded response after ARD103 infusion to the first recorded efficacy result of disease progression, relapse, or death due to any cause, whichever occurs first. PFS: the time from the infusion of ARD103 in the parent study to the first recorded response of disease progression, relapse, or death due to any cause, whichever occurs first.
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This trial is not recruiting at the moment. You can still explore other options:
