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

Plain Language Summary

Simplified for easier understanding

This study tests a new CAR-T cell therapy called ARD103 in people whose acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) has come back or stopped responding to treatment. CAR-T therapy re-engineers your own immune cells to recognize and destroy cancer cells. **You may be eligible if...** - You have been diagnosed with AML that has relapsed or is not responding to treatment, or MDS with at least 5% blast cells in the bone marrow - You are in good physical condition (ECOG 0 or 1) - Your kidneys, liver, and heart are functioning adequately **You may NOT be eligible if...** - You have an active, uncontrolled infection (including HIV) - You have serious organ failure - You are pregnant or unwilling to use contraception - You have previously received certain types of cell or gene therapy targeting the same protein Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)

Novant Health Cancer Institute

Charlotte, North Carolina, United States

Novant Health Cancer Institute

Winston-Salem, North Carolina, United States

MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06680752


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