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

ARCE Therapeutics, Inc.

Status: Begins enrollment in 1 month

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

Treatments: Other: Non interventional study

Study type: Observational

Funder types: Industry

Identifiers

NCT06906380

ARD103_ARCE-CL-P-002

Details and patient eligibility

About

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

Full description

Participants who receive administration of ARD103 (i.e., a partial dose or a full dose) will roll into the LTFU study upon completion of the 24-month interventional study period (Study: ARD103_ARCE-CL-P-001), or after early discontinuation from the interventional study protocol. The LTFU study is a study intended to characterize long-term safety for 15 years post-ARD103 administration. Participants who complete the full 24-month interventional study period will undergo an additional 13 years of monitoring under the LTFU study. No IP will be administered during the LTFU study. The number and percentage of participants with ARD103 CAR-T cell therapy related AEs, SAEs, and AESIs will be recorded throughout the LTFU Period.

Enrollment: 49 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

49 participants in 1 patient group

Non Interventional

Description:

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.

Treatment:

Other: Non interventional study