---
title: A Long-term Follow-up Study of Patients With ARD103 CAR-T Cell Therapies
nct_id: NCT06906380
overall_status: NOT_YET_RECRUITING
sponsor: ARCE Therapeutics, Inc.
study_type: OBSERVATIONAL
primary_condition: Acute Myeloid Leukemia, in Relapse
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06906380.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06906380"
ct_last_update_post_date: 2025-12-08
last_seen_at: "2026-05-12T06:58:41.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Long-term Follow-up Study of Patients With ARD103 CAR-T Cell Therapies

**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

**NCT ID:** [NCT06906380](https://clinicaltrials.gov/study/NCT06906380)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 49
- **Lead Sponsor:** ARCE Therapeutics, Inc.
- **Conditions:** Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia, in Relapsed or Refractory, MDS (Myelodysplastic Syndrome)
- **Start Date:** 2026-03-15
- **Completion Date:** 2040-10-31
- **CT.gov Last Update:** 2025-12-08

## 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.

## Eligibility

- **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
```

## Arms

- **Non Interventional** — 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.

## Interventions

- **Non interventional study** (OTHER) — Non Intervention, an observation LTFU study

## Primary Outcomes

- **The incidence and duration of AEs, SAEs, and AESIs related to ARD103 treatment.** _(time frame: 15 years)_ — The number and percentages of participants experiencing TEAEs will be tabulated. Serious TEAEs will be summarized and AESIs will be summarized.

## Secondary Outcomes

- **The long-term efficacy of ARD103 in participants with R/R AML or MDS** _(time frame: 15 years)_

## Locations (3)

- Novant Health Cancer Institute, Charlotte, North Carolina, United States
- Novant Health Cancer Institute, Winston-Salem, North Carolina, United States
- MD Anderson Cancer Center, Houston, Texas, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.novant health cancer institute|charlotte|north carolina|united states` — added _(2026-05-12)_
- `locations.novant health cancer institute|winston-salem|north carolina|united states` — added _(2026-05-12)_
- `locations.md anderson cancer center|houston|texas|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06906380.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06906380*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*