Clinical Study of ARD103 CAR-T Therapy for Patients With R/R AML or MDS
Sponsor: ARCE Therapeutics, Inc.
ClinicalTrials ID:NCT06680752
This phase I/II study evaluates ARD103, a CLL-1 targeting CAR-T therapy, in patients with R/R AML or MDS. Eligible participants must have adequate organ function and ECOG status 0-1. Interventions include ARD103 infusion and lymphodepletion with cyclophosphamide and fludarabine. Participants must consent and adhere to contraception guidelines.
Patient Parameters
| Parameter | Options |
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Program Overview
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.
Description
The investigational product (IP) for this study is ARD103, a C-type lectin-like molecule-1 (CLL-1) autologous chimeric antigen receptor T-cells (CAR-T). CLL-1 is highly expressed on both myeloid blasts and leukemia stem cells (LSCs) but is absent on normal hematopoietic stem cells (HSCs), suggesting CLL-1 as an excellent therapeutic target for AML and hence other potential myeloid malignancies.
Eligibility Criteria
Inclusion Criteria
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Documented diagnosis of AML with either refractory or relapsed disease or diagnosis of MDS and ≥ 5% BM blasts
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Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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Adequate hematologic status:
- Absolute lymphocyte count (ALC) > 100/mm3
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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
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Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test
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Contraception: males and females of childbearing potential must agree to use an effective method of contraception
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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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Novant Health Cancer Institute | 28204 | Charlotte | North Carolina |
| Novant Health Cancer Institute | 27201 | Winston Salem | North Carolina |
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