ARCE Therapeutics, Inc.
This study will evaluate the long-term safety of ARD103 cellular therapies
Acute Myeloid Leukemia, in Relapse
Acute Myeloid Leukemia, in Relapsed or Refractory
MDS (Myelodysplastic Syndrome)
Non interventional study
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 |
| Estimated Enrollment : | 49 participants |
| Official Title : | A Long-term Follow-up Study of Patients Enrolled in ARD103_ARCE-CL-P-001 Phase 1/2 Study and Treated With ARD103 CAR-T Cell Therapies |
| Actual Study Start Date : | 2025-05-07 |
| Estimated Primary Completion Date : | 2040-05-30 |
| Estimated Study Completion Date : | 2040-10-31 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
No Location Found