Recruiting

ARD103

Sponsor:

ARCE Therapeutics, Inc.

Code:

NCT06906380

Conditions

Acute Myeloid Leukemia, in Relapse

Acute Myeloid Leukemia, in Relapsed or Refractory

MDS (Myelodysplastic Syndrome)

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Non interventional study

Study Details

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)

Study ID

NCT06906380

Start date

May 12, 2026

Status verified date

Oct, 2026

Completion date

Oct 31, 2040

Anticipated

Primary completion date

May 30, 2040

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • There are no specific exclusion criteria for this study

Study Design

Enrollment

49 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Non interventional study

Non Intervention, an observation LTFU study

Primary outcome measure

  • The incidence and duration of AEs, SAEs, and AESIs related to ARD103 treatment. [ Time Frame: 15 years ]

Central Contacts and Locations

Central contacts

ARCE Therapeutics, Inc ARCE

+886-2-26581868contact@arcetherapeutics.com

Locations

Novant Health Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Kunal Shah

980-302-6297kashah@novanthealth.org

Novant Health Cancer Institute

Recruiting

Winston-Salem, North Carolina, United States, 27201

Contacts

Gait Jordan

336-718-8553PJordan@novanthealth.org

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Dr. Abhishek Maiti

713-745-3228AMaiti@mdanderson.org

More Information

Sponsor

ARCE Therapeutics, Inc.

Last update posted

Oct 30, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-31. This information was provided to ClinicalTrials.gov by ARCE Therapeutics, Inc. on 2026-10-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.