NCT06680752 Clinical Study of ARD103 CAR-T Therapy for Patients With R/R AML or MDS
| NCT ID | NCT06680752 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | ARCE Therapeutics, Inc. |
| Condition | Acute Myeloid Leukemia, in Relapse |
| Study Type | INTERVENTIONAL |
| Enrollment | 49 participants |
| Start Date | 2025-05-20 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 49 participants in total. It began in 2025-05-20 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06680752 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Myeloid Leukemia, in Relapse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06680752 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06680752 currently recruiting?
Yes, NCT06680752 is actively recruiting participants. Contact the research team at contact@arcetherapeutics.com for enrollment information.
Where is the NCT06680752 trial being conducted?
This trial is being conducted at Charlotte, United States, Winston-Salem, United States, Houston, United States.
Who is sponsoring the NCT06680752 clinical trial?
NCT06680752 is sponsored by ARCE Therapeutics, Inc.. The trial plans to enroll 49 participants.
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