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NCT06680752 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory, sponsored by ARCE Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
49
Enrollment target
3
Study locations

NCT06680752 is a Phase 1 study of Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory that is actively recruiting participants, run by ARCE Therapeutics. The registered enrollment target is 49 participants, below the 57-participant average among 16 other Acute Myeloid Leukemia, in Relapse trials with a reported enrollment target (14% lower). The trial reports 3 study locations across 2 states.

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The verdict

NCT06680752, a Phase 1 study of Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory, is actively recruiting participants, sponsored by ARCE Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
49 participants
Enrollment target
3
Study locations

Study 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.

Conditions Studied

Acute Myeloid Leukemia, in Relapse Acute Myeloid Leukemia Refractory MDS (Myelodysplastic Syndrome)

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • BIOLOGICAL ARD103

Study Locations (3)

North Carolina

  • Novant Health Cancer Institute - Charlotte
  • Novant Health Cancer Institute - Winston-Salem

Texas

  • MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2025-05-20
Est. Completion 2028-12
Phase Phase 1

Sponsor

ARCE Therapeutics

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06680752

The ClinicalTrials.gov registry entry for NCT06680752 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 57-participant average among 16 other Acute Myeloid Leukemia, in Relapse trials with a reported enrollment target (14% lower). The listed sponsor is ARCE Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Acute Myeloid Leukemia, in Relapse appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.

NCT06680752 reports 3 study locations spanning 2 distinct geographic areas - top geographies include North Carolina, Texas.

Frequently Asked Questions

What is clinical trial NCT06680752 about?

NCT06680752 is a clinical study titled "Clinical Study of ARD103 CAR-T Therapy for Patients With R/R AML or MDS". 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.

What is the current status of trial NCT06680752?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2025-05-20. Estimated completion is 2028-12.

What conditions does trial NCT06680752 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory, MDS (Myelodysplastic Syndrome).

What interventions are being tested in trial NCT06680752?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), ARD103 (BIOLOGICAL).

Who is sponsoring clinical trial NCT06680752?

This trial is sponsored by ARCE Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06680752 being conducted?

This trial has 3 study locations across North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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