NCT06680752 · ARCE Therapeutics, Inc.
Clinical Study of ARD103 CAR-T Therapy for Patients With R/R AML or MDS
What this study is about
This is a phase I/2, interventional, where both patients and doctors know the treatment given, conducted at multiple hospitals study to assess the safety and effectiveness of ARD103 in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.
View original scientific description
This is a phase I/2, interventional, open-label, multicenter study to assess the safety and efficacy of ARD103 in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.
Interventions
BIOLOGICAL
ARD103
ARD103 autologous CAR-T cell therapy targeting CLL-1, single iv. infusion
DRUG
Cyclophosphamide
iv administration for lymphodepletion
DRUG
Fludarabine
iv administration for lymphodepletion
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 28 days post ARD103 infusion
The records of AEs and severity following the first infusion of ARD103.
To determine the RP2D of ARD103
Time frame: 28 days post ARD103 infusion
RP2D of ARD103 following a 3+3 dose escalation schema (Phase 1)
To evaluate overall response rate (ORR)
Time frame: Up to 24 months
The ORR will be evaluated by European Leukemia Net (ELN) criteria
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- Participants with acute promyelocytic leukemia
- Presence of active and clinically relevant central nervous system (CNS) disorder
- Autoimmune disease requiring immunosuppressive treatment
Where
- Charlotte, North Carolina
- Winston-Salem, North Carolina
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 10, 2025 · Source of record for eligibility and locations