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 (Jun 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
Treatments studied
Chemotherapy
Other
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 →Frequently asked questions
Is NCT06680752 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior investigational gene or cell therapy, chemotherapy, biologic/targeted therapy, or immunological agents directed to the pathology disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify