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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| phase 1 (Dose Escalation) and phase 2 (Dose Expansion) | Experimental | In Phase 1, three escalating dose levels will be tested using the 3 + 3 design. The MTD and RP2D will be identified. The Phase 2 will be conducted in 2 stages. In Stage I, evaluable participants from Phase 1 treated at RP2D will be enrolled. And the enrollment will continue into Stage II (additional evaluable participants) at the maximum RP2D participants for preliminary overall assessment of efficacy and safety. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARD103 | Biological | ARD103 autologous CAR-T cell therapy targeting CLL-1, single iv. infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | The records of AEs and severity following the first infusion of ARD103. | 28 days post ARD103 infusion |
| To determine the RP2D of ARD103 | RP2D of ARD103 following a 3+3 dose escalation schema (Phase 1) | 28 days post ARD103 infusion |
| To evaluate overall response rate (ORR) | The ORR will be evaluated by European Leukemia Net (ELN) criteria | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from ARD103 infusion to the date of death from any cause. | First infusion date of ARD103 up to 15 years |
| Progression-free survival (PFS) | PFS is defined as the time from the infusion of ARD103 infusion to the first recorded response of disease progression, relapse, or death due to any cause, whichever occurs first. |
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Inclusion Criteria:
Documented diagnosis of AML with either refractory or relapsed disease or diagnosis of MDS and ≥ 5% BM blasts
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate hematologic status:
Adequate renal, hepatic, cardiac and pulmonary function:
Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test
Contraception: males and females of childbearing potential must agree to use an effective method of contraception
Participant is capable of giving signed informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ARCE Therapeutics, Inc | Contact | +886-2-26581868 | contact@arcetherapeutics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novant Health Cancer Institute | Recruiting | Charlotte | North Carolina | 28204 | United States |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| Cyclophosphamide | Drug | iv administration for lymphodepletion |
|
| Fludarabine | Drug | iv administration for lymphodepletion |
|
| Up to 24 months |
| Time to best response | Time to best response is defined as the time from the infusion of ARD103 to the BOR. | First infusion date of ARD103 up to 24 months |
| Novant Health Cancer Institute | Recruiting | Winston-Salem | North Carolina | 27201 | United States |
|
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000753 | Anemia, Refractory |
| D000740 | Anemia |
| D009190 | Myelodysplastic Syndromes |
| D001855 | Bone Marrow Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |