Actively Recruiting
Clinical Study of ARD103 CAR-T Therapy for Patients With R/R AML or MDS
Led by ARCE Therapeutics, Inc. · Updated on 2025-12-10
49
Participants Needed
3
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Study of ARD103 CAR-T Therapy for Patients With R/R AML or MDS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented diagnosis of AML with refractory or relapsed disease or diagnosis of MDS with at least 5% bone marrow blasts
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Absolute lymphocyte count greater than 100/mm3
- Adequate liver function with ALT and AST less than 3 times the upper limit of normal
- Creatinine clearance of at least 45 mL/min estimated by Cockcroft-Gault and no dialysis
- Total bilirubin 2.0 mg/dL or less
- Negative pregnancy test for females of childbearing potential
- Agreement to use effective contraception for males and females of childbearing potential
- Ability to provide signed informed consent
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia
- Active and clinically relevant central nervous system disorder
- Autoimmune disease requiring immunosuppressive treatment
- Known hepatic bridging cirrhosis
- Active infection with hepatitis B or C
- Previous treatment with investigational gene or cell therapies including CAR-T
- Active acute graft-versus-host disease or systemic steroids over 10 mg prednisone daily
- Chemotherapy including biologic or immunological agents within 14 days prior to screening and during the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Novant Health Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
2
Novant Health Cancer Institute
Winston-Salem, North Carolina, United States, 27201
Actively Recruiting
3
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
ARCE Therapeutics, Inc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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