NCT06680752RecruitingPhase 1/2
Clinical Study of ARD103 CAR-T Therapy for Patients With R/R AML or MDS
A Phase 1/2, Open-label, Multicenter Trial to Assess the Safety and Efficacy of ARD103 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
Source: ClinicalTrials.gov · Last updated 10 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 49 (estimated)
- First submitted
- 29 Oct 2024
- Start date
- May 2025
- Primary completion date
- Oct 2028
- Lead sponsor
- ARCE Therapeutics, Inc.
- NCT number
- NCT06680752
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 49
- From May 2025 to the primary completion date, Oct 2028
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with investigational gene or cell therapy (including CAR therapy)
- 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
Other illness
- Presence of active and clinically relevant central nervous system (CNS) disorder
- Autoimmune disease requiring immunosuppressive treatment
- Currently active infection with hepatitis B or C
Other
- Participants with acute promyelocytic leukemia
- Participants with known hepatic bridging cirrhosis
- Any active acute GvHD or systemic treatment of more than 10 mg prednisone daily (or equivalent)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novant Health Cancer Institute Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Novant Health Cancer Institute Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.