Clinical trial · Observational
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
NCT06906380CI-TRIAL-00098608not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will evaluate the long-term safety of ARD103 cellular therapies
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia, in Relapse | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Acute Myeloid Leukemia, in Relapsed or Refractory | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| MDS (Myelodysplastic Syndrome) | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non interventional study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Non Interventional
- description
- 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.
- interventionNames
- Other: Non interventional study
Primary outcomes (1)
- measure
- The incidence and duration of AEs, SAEs, and AESIs related to ARD103 treatment.
- timeFrame
- 15 years
- description
- The number and percentages of participants experiencing TEAEs will be tabulated. Serious TEAEs will be summarized and AESIs will be summarized.
Secondary outcomes (1)
- measure
- The long-term efficacy of ARD103 in participants with R/R AML or MDS
- timeFrame
- 15 years
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.