OncoMatch/Clinical Trials/NCT06680752
Clinical Study of ARD103 CAR-T Therapy for Patients With R/R AML or MDS
Is NCT06680752 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including ARD103 and Cyclophosphamide for acute myeloid leukemia, in relapse.
Treatment: ARD103 · Cyclophosphamide · Fludarabine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: investigational gene or cell therapy (CAR therapy)
Previous treatment with investigational gene or cell therapy (including CAR therapy)
Cannot have received: chemotherapy, biologic/targeted therapy, or immunological agents directed to the pathology
Exception: within 14 days prior to screening and all along the study duration
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
Lab requirements
Blood counts
Absolute lymphocyte count (ALC) > 100/mm3
Kidney function
Creatinine clearance ≥ 45.0 mL/min as estimated by Cockcroft-Gault and independent dialysis
Liver function
ALT and AST < 3.0 × the ULN; Total bilirubin ≤ 2.0 mg/dL
Cardiac function
Adequate cardiac function required
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Novant Health Cancer Institute · Charlotte, North Carolina
- Novant Health Cancer Institute · Winston-Salem, North Carolina
- MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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