Study on ARD103 CAR-T Therapy for Patients with Difficult-to-Treat Acute Myeloid Leukemia or Myelodysplastic Syndrome
Sponsor: ARCE Therapeutics, Inc.
ClinicalTrials ID:NCT06680752
This clinical trial is testing a new treatment called ARD103 CAR-T therapy to see if it is safe and effective for patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that has not responded to previous treatments or has returned.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate the safety and effectiveness of a new treatment called ARD103 CAR-T therapy in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that has either not responded to previous treatments or has come back. This treatment uses modified immune cells to target and attack cancer cells.
Description
This study is testing a new treatment called ARD103, which is a type of CAR-T therapy. CAR-T therapy involves taking a patient's own immune cells, modifying them in a lab to better recognize and attack cancer cells, and then returning them to the patient's body. ARD103 specifically targets a molecule called CLL-1, which is found on cancerous cells in AML and MDS but not on normal blood cells. This makes it a promising target for treating these diseases. The study will assess how safe and effective this treatment is for patients whose AML or MDS has not responded to other treatments or has returned after treatment.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of acute myeloid leukemia (AML) that has not responded to treatment or has returned, or have myelodysplastic syndrome (MDS) with at least 5% abnormal cells in the bone marrow.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate blood cell counts, including a lymphocyte count greater than 100/mm3.
- Have good kidney, liver, heart, and lung function as indicated by specific blood tests.
- Women of childbearing potential must have a negative pregnancy test before starting treatment.
- Agree to use effective contraception during the study if of childbearing potential.
- Be able to understand and sign an informed consent form.
Exclusion Criteria
- Have a type of leukemia called acute promyelocytic leukemia.
- Have an active and significant disorder affecting the central nervous system.
- Have an autoimmune disease that requires treatment with immunosuppressive drugs.
- Have severe liver disease known as hepatic bridging cirrhosis.
- Have an active infection with hepatitis B or C.
- Have previously received gene or cell therapy, including CAR-T therapy.
- Have active graft-versus-host disease (GvHD) or are taking more than 10 mg of prednisone daily.
- Have received chemotherapy or other targeted treatments within 14 days before starting the study.
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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