A Long-term Follow-up Study of Patients With ARD103 CAR-T Cell Therapies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-03-15

Study Completion Date

2040-10-31

Brief Summary

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This study will evaluate the long-term safety of ARD103 cellular therapies

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Detailed Description

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Participants who receive administration of ARD103 (i.e., a partial dose or a full dose) will roll into the LTFU study upon completion of the 24-month interventional study period (Study: ARD103\_ARCE-CL-P-001), or after early discontinuation from the interventional study protocol. The LTFU study is a study intended to characterize long-term safety for 15 years post-ARD103 administration. Participants who complete the full 24-month interventional study period will undergo an additional 13 years of monitoring under the LTFU study. No IP will be administered during the LTFU study. The number and percentage of participants with ARD103 CAR-T cell therapy related AEs, SAEs, and AESIs will be recorded throughout the LTFU Period.

Conditions

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Acute Myeloid Leukemia, in Relapse Acute Myeloid Leukemia, in Relapsed or Refractory MDS (Myelodysplastic Syndrome)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non Interventional

All subjects with AML or MDS who are enrolled in a parent study and were exposed to ARD103 CAR-T cellular therapy will be asked to participate in this long-term follow-up (LTFU) study.

Non interventional study

Intervention Type OTHER

Non Intervention, an observation LTFU study

Interventions

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Non interventional study

Non Intervention, an observation LTFU study

Intervention Type OTHER

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No