Drugs / ARD103
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT06680752 | May 2025 → Oct 2028 expected | acute myeloid leukemia, myelodysplastic syndrome | ARCE Therapeutics, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2024-11-22 | ARCE Therapeutics, Inc. | Regulatory 承寶生技ARD103 CAR-T獲美國FDA孤兒藥資格認定，上巿可享7年巿場獨賣期 arcetherapeutics.com ↗
承寶生技今 (22) 日宣布 ， 開發中新藥 ARD103 CAR-T ， 獲美國食品藥物管理局 (FDA) 授予 治療急性骨髓性白血病 (AML) 孤兒藥認定 (Orphan Drug Designation, ODD) 。 |
| 2024-10-18 | ARCE Therapeutics, Inc. | Regulatory 承寶生技ARD103 CAR-T獲美國FDA一/二期臨床試驗申請通過，用來治療罕見疾病急性骨髓性白血病 arcetherapeutics.com ↗
承寶生技旗下用於治療罕見疾病急性骨髓性白血病 (AML) 之細胞治療新藥 ARD103 CAR-T ，通過美國食品藥物管理局 (FDA) 人體試驗新藥審查 (IND) ，准予進行一 / 二期臨床試驗，預計明年第一季啟動臨床試驗並納入收案。 |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-11-22 | ARCE Therapeutics, Inc. | 承寶生技ARD103 CAR-T獲美國FDA孤兒藥資格認定，上巿可享7年巿場獨賣期 arcetherapeutics.com ↗ |
| 2024-10-18 | ARCE Therapeutics, Inc. | 承寶生技ARD103 CAR-T獲美國FDA一/二期臨床試驗申請通過，用來治療罕見疾病急性骨髓性白血病 arcetherapeutics.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ARD103 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06680752 ↗ |
| Modality | Cell therapy | “ARD103 autologous CAR-T cell therapy targeting CLL-1” NCT06680752 ↗ |
| Route | Intravenous | “single iv. infusion” NCT06680752 ↗ |