Acute Myeloid Leukemia, in RelapseNCT06906380
A Long-term Follow-up Study of Patients With ARD103 CAR-T Cell Therapies
An observational study of Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia, in Relapsed or Refractory, run by ARCE Therapeutics, Inc. at 3 sites in United States.
Trial summary
This study will evaluate the long-term safety of ARD103 cellular therapies Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia, in Relapsed or Refractory, MDS (Myelodysplastic Syndrome)
- What is being tested?
- Non interventional study
- How many people
- 49 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 May 2026to 31 Oct 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- There are no specific exclusion criteria for this study
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Novant Health Cancer Institute
Charlotte, North Carolina, 28204
Kunal Shah, 980-302-6297, kashah@novanthealth.org
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Dr. Abhishek Maiti, 713-745-3228, AMaiti@mdanderson.org
- Recruiting
Novant Health Cancer Institute
Winston-Salem, North Carolina, 27201
Gait Jordan, 336-718-8553, PJordan@novanthealth.org
About this study
Official 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
This study will evaluate the long-term safety of ARD103 cellular therapies
Read the 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.
- Conditions
- Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia, in Relapsed or Refractory, MDS (Myelodysplastic Syndrome)
- Being tested
- Non interventional study
- Medical subject headings
- Leukemia, Myeloid, Acute, Anemia, Refractory, with Excess of Blasts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventional studyOther
Non Intervention, an observation LTFU study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Non interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and duration of AEs, SAEs, and AESIs related to ARD103 treatment.
The number and percentages of participants experiencing TEAEs will be tabulated. Serious TEAEs will be summarized and AESIs will be summarized.
Measured: 15 years
Secondary outcomes (1)
The long-term efficacy of ARD103 in participants with R/R AML or MDS
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.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start12 May 2026
- Primary completion30 May 2040 (estimated)
- Study completion31 Oct 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia, in RelapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ARCE Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906380
- Sponsor's protocol ID
- ARD103_ARCE-CL-P-002
- Status last verified
- Oct 2026
- First submitted
- 26 Mar 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06906380
- Acronym / sponsor ID
- ARD103_ARCE-CL-P-002
- Conditions
- Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia, in Relapsed or Refractory, MDS (Myelodysplastic Syndrome)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- ARCE Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 May 2026 (actual)
- Primary completion
- 30 May 2040 (estimated)
- Study completion
- 31 Oct 2040 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the long-term safety of ARD103 cellular therapies
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non Interventional | – | Other: Non interventional studyAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non interventional studyNon Intervention, an observation LTFU study | Other | Non Interventional |
Primary outcome
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.
1 secondary outcome
The long-term efficacy of ARD103 in participants with R/R AML or MDS
Time frame: 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia, in Relapsed or Refractory, run by ARCE Therapeutics, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ARCE Therapeutics, Inc ARCE (+886-2-26581868, contact@arcetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and duration of AEs, SAEs, and AESIs related to ARD103 treatment. (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.