RecruitingPhase 1Phase 2NCT06680752
Clinical Study of ARD103 CAR-T Therapy for Patients With R/R AML or MDS
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
Sponsor
ARCE Therapeutics, Inc.
Enrollment
49 participants
Start Date
May 20, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria11
- 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 Criteria8
- 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
Interventions
BIOLOGICALARD103
ARD103 autologous CAR-T cell therapy targeting CLL-1, single iv. infusion
DRUGCyclophosphamide
iv administration for lymphodepletion
DRUGFludarabine
iv administration for lymphodepletion
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06680752
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