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
ARCE Therapeutics, Inc.
Summary
This study will evaluate the long-term safety of ARD103 cellular therapies
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 p…
Eligibility
- Age range
- Not specified
- Sex
- 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 exclusion criteria for this study
Interventions
- OtherNon interventional study
Non Intervention, an observation LTFU study
Locations (3)
- Novant Health Cancer InstituteCharlotte, North Carolina
- Novant Health Cancer InstituteWinston-Salem, North Carolina
- MD Anderson Cancer CenterHouston, Texas