Long-term Safety of ARD103 CAR-T Cell Therapy for AML and MDS
This observational study is looking at the long-term safety of ARD103 CAR-T cell therapies in people who have acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) and have already received this treatment in a previous study. The study aims to track any side effects (adverse events or AEs), serious side effects (SAEs), and side effects of special interest (AESIs) related to ARD103 for up to 15 years. You can join if you have R/R AML or MDS and have previously received ARD103 CAR-T cell therapy. This study is currently unclear on its recruitment status and plans to enroll 49 participants.
- Study design
- This is an observational study with no specified phase, planning to enroll 49 participants. It is a long-term follow-up study.
- What's involved
- You would be monitored for up to 15 years after receiving ARD103, with monitoring continuing for 13 years after a 24-month interventional study period.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 15 years to monitor the incidence and duration of side effects related to ARD103 treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Long-term Follow-up Study of Patients With ARD103 CAR-T Cell Therapies
At a glance
Conditions
Where it's being run
3 sites across 2 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- The incidence and duration of AEs, SAEs, and AESIs related to ARD103 treatment.15 years
The number and percentages of participants experiencing TEAEs will be tabulated. Serious TEAEs will be summarized and AESIs will be summarized.