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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The records of AEs and severity following the first infusion of ARD103.

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
ARCE Therapeutics

2 total trials

What NCT06680752 shows while recruiting

NCT06680752 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 57-participant average among 16 other Acute Myeloid Leukemia, in Relapse trials with a reported enrollment target (14% lower).

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 a single indexed study location in 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.

Similar trials for Acute Myeloid Leukemia, in Relapse

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06680752's enrollment target sits among peer trials

49 4th of 16 higher than 13 of 16 other Acute Myeloid Leukemia, in Relapse trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acute Myeloid Leukemia, in Relapse trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06680752, the US trial registry maintained by the National Library of Medicine. NCT06680752 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.