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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non interventional study | Other | Non Intervention, an observation LTFU study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ARCE Therapeutics, Inc ARCE | Contact | +886-2-26581868 | contact@arcetherapeutics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novant Health Cancer Institute | Charlotte | North Carolina | 28204 | United States |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 15 years |
| Novant Health Cancer Institute | Winston-Salem | North Carolina | 27201 | United States |
|
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000753 | Anemia, Refractory |
| D000740 | Anemia |
| D009190 | Myelodysplastic Syndromes |
| D001855 | Bone Marrow Diseases |