A Long-term Follow-up Study of Patients With ARD103 CAR-T Cell Therapies

NCT06906380 | Not Yet Recruiting FDA Drug

• 1 other identifier: ARD103_ARCE-CL-P-002
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 3

Brief Summary

This study will evaluate the long-term safety of ARD103 cellular therapies

Conditions

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

Outcome Measures

Primary Outcomes (1)

• The incidence and duration of AEs, SAEs, and AESIs related to ARD103 treatment.

  The number and percentages of participants experiencing TEAEs will be tabulated. Serious TEAEs will be summarized and AESIs will be summarized.

  15 years

Secondary Outcomes (1)

• The long-term efficacy of ARD103 in participants with R/R AML or MDS

  15 years

Study Arms (1)

Non Interventional

All subjects with AML or MDS who are enrolled in a parent study and were exposed to ARD103 CAR-T cellular therapy will be asked to participate in this long-term follow-up (LTFU) study.

Other: Non interventional study

Interventions

Non interventional study OTHER

Non Intervention, an observation LTFU study

Non Interventional

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will comprise participants with R/R AML or MDS treated with ARD103. All subjects with AML or MDS who are enrolled in a parent study and were received ARD103 CAR-T infusion will be asked to participate in this long-term follow-up (LTFU) study.

You may qualify if:

• The participant has R/R AML or MDS and has previously received ARD103 CAR-T cell therapies in the parent study.
• The participant is able to understand and comply with protocol-required study procedures and has provided a written informed consent document.

Sponsors & Collaborators

• ARCE Therapeutics, Inc.: lead

Study Sites (3)

Novant Health Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Novant Health Cancer Institute

Winston-Salem, North Carolina, 27201, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Anemia, Refractory, with Excess of Blasts

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Refractory; Anemia; Myelodysplastic Syndromes; Bone Marrow Diseases

Central Study Contacts

ARCE Therapeutics, Inc ARCE

CONTACT

+886-2-26581868; contact@arcetherapeutics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: March 15, 2026
• Primary Completion (Estimated): May 30, 2040
• Study Completion (Estimated): October 31, 2040
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

US (3)