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

NCT06680752 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2025-12-10

No results posted yet for this 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

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

Interventions

BIOLOGICAL

ARD103

ARD103 autologous CAR-T cell therapy targeting CLL-1, single iv. infusion

DRUG

Cyclophosphamide

iv administration for lymphodepletion

DRUG

Fludarabine

iv administration for lymphodepletion

Sponsors & Collaborators

  • ARCE Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-20
Primary Completion
2028-10-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06680752 on ClinicalTrials.gov