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

December 4, 2025 updated by: ARCE Therapeutics, Inc.

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
      • Winston-Salem, North Carolina, United States, 27201
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Non interventional study
Non Intervention, an observation LTFU study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARCE Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

May 30, 2040

Study Completion (Estimated)

October 31, 2040

Study Registration Dates

First Submitted

March 26, 2025

First Submitted That Met QC Criteria

March 26, 2025

First Posted (Actual)

April 2, 2025

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARD103_ARCE-CL-P-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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