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 ARD103

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Additional Trial Information

Phase 1/2

Enrollment: 49 patients (estimated)

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Trial Locations

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North Carolina

Novant Health Presbyterian Medical Center Novant Health

Charlotte, NC

Open and Accepting

Novant Health Forsyth Cancer Institute - Bethesda Court

Winston-Salem, NC

Open and Accepting
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