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

N/ANot Yet RecruitingNCT06906380

ARCE Therapeutics, Inc.49 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

Interventions

Non interventional studyOTHER

Non Intervention, an observation LTFU study

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (3)

Novant Health Cancer Institute

Charlotte, North Carolina, United States

Novant Health Cancer Institute

Winston-Salem, North Carolina, United States

MD Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 15 years

Secondary Outcomes

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

Overall survival (OS): the time from the infusion of ARD103 CAR-T in the parent study until death for any cause. Duration of Response (DOR): the time from the first recorded response after ARD103 infusion to the first recorded efficacy result of disease progression, relapse, or death due to any cause, whichever occurs first. PFS: the time from the infusion of ARD103 in the parent study to the first recorded response of disease progression, relapse, or death due to any cause, whichever occurs first.

Time frame: 15 years

Central Contacts

ARCE Therapeutics, Inc ARCE

CONTACT

+886-2-26581868 contact@arcetherapeutics.com

Data from ClinicalTrials.gov

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