Trials / Not Yet Recruiting
Not Yet RecruitingNCT06906380
A Long-term Follow-up Study of Patients With ARD103 CAR-T Cell Therapies
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
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 49 (estimated)
- Sponsor
- ARCE Therapeutics, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
- Acute Myeloid Leukemia, in Relapse
- Acute Myeloid Leukemia, in Relapsed or Refractory
- MDS (Myelodysplastic Syndrome)
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Non interventional study | Non Intervention, an observation LTFU study |
Timeline
- Start date
- 2026-03-15
- Primary completion
- 2040-05-30
- Completion
- 2040-10-31
- First posted
- 2025-04-02
- Last updated
- 2025-12-08
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06906380. Inclusion in this directory is not an endorsement.