A Long-term Follow-up Study of Patients… | Clinical Trial

Key information

Conditions

Acute Myeloid Leukemia, in Relapse Acute Myeloid Leukemia, in Relapsed or Refractory Anemia Anemia, Refractory Anemia, Refractory, with Excess of Blasts Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute MDS (Myelodysplastic Syndrome) Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type

Sex eligibility

All sexes

Study type

Observational

Primary location

Novant Health Cancer Institute, Charlotte, North Carolina, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non interventional study

Other

Non Intervention, an observation LTFU study

Primary outcomes

The incidence and duration of AEs, SAEs, and AESIs related to ARD103 treatment.

Time frame: 15 years

The number and percentages of participants experiencing TEAEs will be tabulated. Serious TEAEs will be summarized and AESIs will be summarized.

Secondary outcomes

The long-term efficacy of ARD103 in participants with R/R AML or MDS

Time frame: 15 years

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.

Study contacts

Contact information is provided by the study sponsor or research team.

ARCE Therapeutics, Inc ARCE

CONTACT

[email protected]

+886-2-26581868

Sponsors and collaborators

Lead sponsor

ARCE Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2040
Study completion: 2040
First posted: Apr 2, 2025
Registry last updated: Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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