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CAR-T therapy survivors monitored for Long-Term safety and survival

NCT ID NCT06906380

Knowledge-focused Sponsor: ARCE Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows up to 49 people with relapsed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who previously received ARD103 CAR-T cell therapy in an earlier trial. Researchers will track side effects, overall survival, and how long any response lasts. The goal is to better understand the long-term safety and effectiveness of this treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 49 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Oct 2040

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia myelodysplastic syndrome myelodysplastic syndrome with excess blasts

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia, in relapse Acute myeloid leukemia, in relapsed or refractory MDS (myelodysplastic syndrome)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    3 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Novant Health Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Novant Health Cancer Institute

    Winston-Salem, North Carolina, 27201, United States

More trials for these conditions

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