Clinical Study of ARD103 CAR-T Therapy for Patients With R/R AML or MDS
Recruiting now · Phase 1/Phase 2
Conditions studied: Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory, MDS (Myelodysplastic Syndrome)
In brief
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.
Key facts
- Study ID
- NCT06680752
- Run by
- ARCE Therapeutics, Inc.
- People needed
- 49
- Starts
- 2025-05-20
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2025-12-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Novant Health Cancer Institute — Charlotte, North Carolina, United States (enrolling)
- Novant Health Cancer Institute — Winston-Salem, North Carolina, United States (enrolling)
- MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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