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Clinical Study of ARD103 CAR-T Therapy for Relapsed/Refractory AML or MDS

This study is testing a new treatment called ARD103, which is a CAR-T cell therapy. This therapy uses your own immune cells, modified to recognize and fight cancer cells that have a specific marker called CLL-1. You would first receive chemotherapy drugs, Cyclophosphamide and Fludarabine, to prepare your body for the ARD103 infusion. This study is for adults with acute myeloid leukemia (AML) that has come back or is not responding to treatment, or with myelodysplastic syndrome (MDS) with a certain percentage of blast cells in the bone marrow. Researchers want to see how safe ARD103 is, what dose works best, and how well it helps patients. The study plans to enroll 49 participants.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It is designed to evaluate the safety and effectiveness of ARD103 in about 49 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor your safety for at least 28 days after the ARD103 infusion. They will also track how well the treatment works for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06680752

Clinical Study of ARD103 CAR-T Therapy for Patients With R/R AML or MDS

Recruiting
PHASE1Ages 18+InterventionalTreatment
ARCE Therapeutics, Inc.
~49 participants
Updated 2025-12-10 on ClinicalTrials.gov
What's tested:ARD103CyclophosphamideFludarabine

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Measured over 28 days post ARD103 infusion
+2 more outcomes measured

Conditions

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

Explore related trials

Acute Myeloid LeukemiaMyelodysplastic Syndrome

Where it's being run

3 sites across 2 states
North Carolina2
Texas1

Who to contact

ARCE Therapeutics, Inc
[email protected]
+886-2-26581868
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Documented diagnosis of AML with either refractory or relapsed disease or diagnosis of MDS and ≥ 5% BM blasts
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate hematologic status:
Absolute lymphocyte count (ALC) \> 100/mm3
Adequate renal, hepatic, cardiac and pulmonary function:
ALT and AST \< 3.0 × the ULN
Creatinine clearance ≥ 45.0 mL/min as estimated by Cockcroft-Gault and independent dialysis
Total bilirubin ≤ 2.0 mg/dL
Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test
Contraception: males and females of childbearing potential must agree to use an effective method of contraception
Participant is capable of giving signed informed consent

Exclusion

Participants with acute promyelocytic leukemia
Presence of active and clinically relevant central nervous system (CNS) disorder
Autoimmune disease requiring immunosuppressive treatment
Participants with known hepatic bridging cirrhosis
Currently active infection with hepatitis B or C
Previous treatment with investigational gene or cell therapy (including CAR therapy)
Any active acute GvHD or systemic treatment of more than 10 mg prednisone daily (or equivalent)
Previous chemotherapy including biologic/targeted therapy or immunological agents directed to the pathology within 14 days prior to screening and all along the study duration

What this trial measures

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]28 days post ARD103 infusion

    The records of AEs and severity following the first infusion of ARD103.

  • To determine the RP2D of ARD10328 days post ARD103 infusion

    RP2D of ARD103 following a 3+3 dose escalation schema (Phase 1)

  • To evaluate overall response rate (ORR)Up to 24 months

    The ORR will be evaluated by European Leukemia Net (ELN) criteria