Drugs / 3D189
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05320809 | Aug 2022 → Jun 2026 overdue | acute leukemia, myelodysplastic syndrome, non-Hodgkin lymphoma, plasma cell myeloma | 3D Medicines | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2023-03-20 | 3D Medicines (Sichuan) Co., Ltd. | Regulatory 思路迪医药宣布肿瘤疫苗3D189获批开展全球多中心Ⅲ期临床试验 3d-medicines.com ↗
中国青岛, 2023年3月19日 – 思路迪医药（3D Medicines, 01244.HK）宣布，公司在研候选药物3D189（galinpepimut-S，GPS）单药治疗经挽救治疗后获得第二次完全缓解的急性髓性白血病（AML）患者的Ⅲ期全球多中心临床试验（MRCT）已获国家药品监督管理局（NMPA）的临床试验许可。 |
| 2022-04-06 | Sellas Life Sciences Group | Regulatory SELLAS Life Sciences Announces Achievement of Development Milestone for Approval of IND for Galinpepimut-S in China sellaslifesciences.com ↗
today announced that an Investigational New Drug (“IND”) application to initiate the first clinical trial in China for 3D189, also known as SELLAS’ galinpepimut-S (GPS), has been approved by China’s National Medical Products Administration (“NMPA”). |
| 2022-04-05 | 3D Medicines (Sichuan) Co., Ltd. | Regulatory 思路迪医药宣布：WT1多肽肿瘤治疗性疫苗新药3D189临床试验申请获批 3d-medicines.com ↗
中国北京，2022年4月5日 - 思路迪医药（3D Medicines Inc.）,一家专注新一代肿瘤免疫治疗创新药研发及商业化的生物医药公司，今日宣布：公司在研候选药物，多肽肿瘤疫苗3D189（亦称：Galinpepimut-S）已获得中国国家药品监督管理局（NMPA）签发的药物临床试验批准通知书，用于开展评估该药品在血液肿瘤患者中的安全性和免疫原性的I期临床研究。 |
| 2022-01-25 | 3D Medicines (Sichuan) Co., Ltd. | Regulatory 探索 WT1 多肽肿瘤疫苗，思路迪医药 3D189 临床试验申请获NMPA受理 3d-medicines.com ↗
2022年1月24日，思路迪医药（3D Medicines Inc.）宣布，3D189（Galinpepimut-S，简称GPS）临床试验申请获得中国国家药品监督管理局（NMPA）受理。 |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-03-20 | 3D Medicines (Sichuan) Co., Ltd. | 思路迪医药宣布肿瘤疫苗3D189获批开展全球多中心Ⅲ期临床试验 3d-medicines.com ↗ |
| 2022-10-11 | Sellas Life Sciences Group | SELLAS Life Sciences’ Licensee, 3D Medicines, Doses First Patient in Phase 1 Clinical Trial in China of Galinpepimut-S sellaslifesciences.com ↗ |
| 2022-04-06 | Sellas Life Sciences Group | SELLAS Life Sciences Announces Achievement of Development Milestone for Approval of IND for Galinpepimut-S in China sellaslifesciences.com ↗ |
| 2022-04-05 | 3D Medicines (Sichuan) Co., Ltd. | 思路迪医药宣布：WT1多肽肿瘤治疗性疫苗新药3D189临床试验申请获批 3d-medicines.com ↗ |
| 2022-01-25 | 3D Medicines (Sichuan) Co., Ltd. | 探索 WT1 多肽肿瘤疫苗，思路迪医药 3D189 临床试验申请获NMPA受理 3d-medicines.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | 3D189 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05320809 ↗ |
| Known as | galinpepimut-S | “This is a phase 1, open-label, non-comparative, multicenter study of 3D189 (also known as galinpepimut-S), a multivalent peptide vaccine targeting Wilms Tumor-1 (WT1), for...” NCT05320809 ↗ |
| Modality | Vaccine | “a multivalent peptide vaccine” NCT05320809 ↗ |
| Route | Subcutaneous | “injected subcutaneously” NCT05320809 ↗ |
| Target | WT1 | “targeting Wilms Tumor-1 (WT1)” NCT05320809 ↗ |