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

ClinicalTrials.gov ID: NCT06680752

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ClinicalTrials.gov public records Last synced Nov 14, 2026, 9:28 AM EST

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT06680752
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: ARCE Therapeutics, Inc.; Industry
Enrollment: 49 participants

Conditions and interventions

Conditions

Interventions

ARD103 Biological
Cyclophosphamide Drug
Fludarabine Drug

Biological · Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 20, 2025 (Actual)
Primary completion: Oct 2028 (Estimated)
Completion: Dec 2028 (Estimated)
Last update posted: Dec 10, 2025

2025 – 2028

United States locations

U.S. sites: 3
U.S. states: 2
U.S. cities: 3

Facility	City	State	ZIP	Site status
Novant Health Cancer Institute	Charlotte	North Carolina	28204	Recruiting
Novant Health Cancer Institute	Winston-Salem	North Carolina	27201	Recruiting
MD Anderson Cancer Center	Houston	Texas	77030	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06680752, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Dec 10, 2025 · Synced Nov 14, 2026