Clinical Study of ARD103 CAR-T Therapy for Patients With R/R AML or MDS
About this study
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.
- Condition
- Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory, MDS (Myelodysplastic Syndrome)
- Tested
- ARD103, Cyclophosphamide, Fludarabine
- Sponsor
- ARCE Therapeutics, Inc.
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 13
- Minimum age: 18 years
- Study condition: Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory, MDS (Myelodysplastic Syndrome)
- 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 8
- 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
3 sites, 3 recruiting
Novant Health Cancer Institute
Charlotte, North Carolina, United States
MD Anderson Cancer Center
Houston, Texas, United States
Novant Health Cancer Institute
Winston-Salem, North Carolina, United States
Contact
-
ARCE Therapeutics, Inc
+886-2-26581868 contact@arcetherapeutics.com
Potential match only. Final eligibility is determined by the study team.