A Long-term Follow-up Study of Patients With ARD103 CAR-T Cell Therapies
A Long-term Follow-up Study of Patients Enrolled in ARD103_ARCE-CL-P-001 Phase 1/2 Study and Treated With ARD103 CAR-T Cell Therapies
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- No age limits stated
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 15 years
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The LTFU study is a study intended to characterize long-term safety for 15 years post-ARD103 administration."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study checks the long-term safety of ARD103 CAR-T cell therapies. It is for people with AML or MDS who received these therapies in the earlier study.
This study will evaluate the long-term safety of ARD103 cellular therapies
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You have AML (a blood and bone marrow cancer) or MDS (a disease that affects how blood cells are made) that came back or did not respond to treatment.
- You received ARD103 CAR-T cell therapies in the earlier study.
- You can understand and follow the study steps and have signed a form agreeing to take part.
Who can't join
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: * There are no specific exclusion criteria for this study
Study sites (3)
NC
- Novant Health Cancer Institute · Charlotte, NC 28204Kunal Shah · Study contact · 980-302-6297 · kashah@novanthealth.orgMore trials in Charlotte
- Novant Health Cancer Institute · Winston-Salem, NC 27201Gait Jordan · Study contact · 336-718-8553 · PJordan@novanthealth.orgMore trials in Winston-Salem
TX
- MD Anderson Cancer Center · Houston, TX 77030Dr. Abhishek Maiti · Study contact · 713-745-3228 · AMaiti@mdanderson.orgMore trials in Houston