Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia, in Relapsed or Refractory, MDS (Myelodysplastic Syndrome)
Conditions
Brief summary
This study will evaluate the long-term safety of ARD103 cellular therapies
Detailed 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.
Interventions
OTHERNon interventional study
Non Intervention, an observation LTFU study
Sponsors
ARCE Therapeutics, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence and duration of AEs, SAEs, and AESIs related to ARD103 treatment. | 15 years | The number and percentages of participants experiencing TEAEs will be tabulated. Serious TEAEs will be summarized and AESIs will be summarized. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The long-term efficacy of ARD103 in participants with R/R AML or MDS | 15 years | 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. |
Countries
United States
Contacts
Primary ContactARCE Therapeutics, Inc ARCE
Outcome results
None listed