Drugs / BL-M11D1
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06714591 | Dec 2024 → Sep 2026 | acute myeloid leukemia | SystImmune Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT05924750 | Aug 2023 → Dec 2026 expected | acute myeloid leukemia | Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07591168 | May 2026 → Dec 2028 expected | myelodysplastic syndrome | Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07255872 | Apr 2026 → Dec 2027 expected | acute myeloid leukemia | Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-03-05 | Sichuan Biokin Pharmaceutical Co., Ltd. | Regulatory 四川百利天恒药业股份有限公司自愿披露关于注射用BL-M11D1（CD33-ADC）用于治疗复发或难治性骨髓增生异常综合征获得药物临床试验批准通知书的公告 cninfo.com.cn ↗ |
| 2025-04-23 | Sichuan Biokin Pharmaceutical Co., Ltd. | Regulatory 四川百利天恒药业股份有限公司自愿披露关于BL-M11D1（CD33-ADC）联合用药治疗新诊断的急性髓系白血病获得药物临床试验批准通知书的公告 cninfo.com.cn ↗ |
| 2024-10-14 | Sichuan Biokin Pharmaceutical Co., Ltd. | Regulatory 四川百利天恒药业股份有限公司自愿披露关于BL-M11D1（CD33-ADC）用于治疗复发或难治性急性髓系白血病患者的I期临床试验申请获得FDA许可的公告 cninfo.com.cn ↗ |
| 2024-10-13 | SystImmune Inc. | Regulatory SystImmune, Inc. Announces FDA Clearance of IND Application for BL-M11D1 in Relapsed/Refractory Acute Myeloid Leukemia systimmune.com ↗
SystImmune, Inc (SystImmune), a clinical-stage biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for BL-M11D1, an antibody-drug conjugate (ADC) binding CD33, a protein on myeloid cells. |
| 2023-04-24 | Sichuan Biokin Pharmaceutical Co., Ltd. | Regulatory 四川百利天恒药业股份有限公司自愿披露关于BL-M11D1（CD33-ADC）用于治疗急性髓系白血病获得I期临床试验批准通知书的公告 cninfo.com.cn ↗ |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-03-05 | Sichuan Biokin Pharmaceutical Co., Ltd. | 四川百利天恒药业股份有限公司自愿披露关于注射用BL-M11D1（CD33-ADC）用于治疗复发或难治性骨髓增生异常综合征获得药物临床试验批准通知书的公告 cninfo.com.cn ↗ |
| 2025-04-23 | Sichuan Biokin Pharmaceutical Co., Ltd. | 四川百利天恒药业股份有限公司自愿披露关于BL-M11D1（CD33-ADC）联合用药治疗新诊断的急性髓系白血病获得药物临床试验批准通知书的公告 cninfo.com.cn ↗ |
| 2024-10-14 | Sichuan Biokin Pharmaceutical Co., Ltd. | 四川百利天恒药业股份有限公司自愿披露关于BL-M11D1（CD33-ADC）用于治疗复发或难治性急性髓系白血病患者的I期临床试验申请获得FDA许可的公告 cninfo.com.cn ↗ |
| 2024-10-13 | SystImmune Inc. | SystImmune, Inc. Announces FDA Clearance of IND Application for BL-M11D1 in Relapsed/Refractory Acute Myeloid Leukemia systimmune.com ↗ |
| 2023-04-24 | Sichuan Biokin Pharmaceutical Co., Ltd. | 四川百利天恒药业股份有限公司自愿披露关于BL-M11D1（CD33-ADC）用于治疗急性髓系白血病获得I期临床试验批准通知书的公告 cninfo.com.cn ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BL-M11D1 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06714591 ↗ |
| Route | Intravenous | “Administration by intravenous infusion” NCT05924750 ↗ |