Clinical Study of ARD103 CAR-T Therapy for Patients With R/R AML or MDS

Launched by ARCE THERAPEUTICS, INC. · Nov 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ARD103 CAR-T therapy for patients with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The goal is to find out how safe and effective this therapy is for patients who have not responded to other treatments or whose disease has come back after treatment. This trial is in the early phase, meaning researchers are just starting to gather information about the therapy.

To participate in this study, patients must have a confirmed diagnosis of AML or MDS and meet specific health requirements, such as having a good performance status and adequate blood and organ function. Participants will undergo monitoring and treatment at multiple locations, and they will be required to sign consent forms to ensure they understand the trial and its risks. It's important to note that the study is not yet recruiting participants, so there may be a wait before it begins. Overall, this trial offers a potential new option for patients facing difficult challenges with their current treatments.

Gender

ALL

Eligibility criteria

• 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