Trials / Recruiting
RecruitingNCT06680752
Clinical Study of ARD103 CAR-T Therapy for Patients With R/R AML or MDS
A Phase 1/2, Open-label, Multicenter Trial to Assess the Safety and Efficacy of ARD103 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 49 (estimated)
- Sponsor
- ARCE Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase I/2, interventional, open-label, multicenter study to assess the safety and efficacy of ARD103 in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.
Detailed description
The investigational product (IP) for this study is ARD103, a C-type lectin-like molecule-1 (CLL-1) autologous chimeric antigen receptor T-cells (CAR-T). CLL-1 is highly expressed on both myeloid blasts and leukemia stem cells (LSCs) but is absent on normal hematopoietic stem cells (HSCs), suggesting CLL-1 as an excellent therapeutic target for AML and hence other potential myeloid malignancies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ARD103 | ARD103 autologous CAR-T cell therapy targeting CLL-1, single iv. infusion |
| DRUG | Cyclophosphamide | iv administration for lymphodepletion |
| DRUG | Fludarabine | iv administration for lymphodepletion |
Timeline
- Start date
- 2025-05-20
- Primary completion
- 2028-10-01
- Completion
- 2028-12-01
- First posted
- 2024-11-08
- Last updated
- 2025-12-10
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06680752. Inclusion in this directory is not an endorsement.