Tests BL-M11D1 in adults with relapsed or hard-to-treat acute myeloid leukemia
Tests BL-M11D1 for safety and tolerable doses in adults with returned or resistant leukemia.
Plain-language title generated from the registry record
Registry title: A Study of BL-M11D1 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Key facts
- Where
- Beijing, Chengdu, Haerbin, Hefei, Jinan, Shanghai, Shenyang, and Tianjin, ChinaSee the 8 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 75 with CD33-positive acute myeloid leukemia that has come back or has not responded to earlier treatment.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- CD33-positive relapsed/refractory acute myeloid leukemia (AML), confirmed by tissue or cell tests, with 5% or more blasts in the bone marrow. ECOG performance status of 2 or lower. Expected survival of 3 months or more.
- Earlier treatment
- Side effects from earlier cancer treatment must have recovered to Grade 1 or less. No cancer treatment in the 4 weeks (or 5 half-lives, whichever is shorter) before the first dose.
- Biomarker or test result
- CD33-positive leukemia. White blood cell count of 25×10^9/L or lower before the first dose.
Main reasons for not taking part
- Acute promyelocytic leukemia, or chronic myeloid leukemia that turned acute
- Leukemia in the central nervous system
- Earlier organ transplant or allogeneic stem cell transplant
- Severe heart disease, or HIV, active tuberculosis, active hepatitis B or C
- Pregnant or breastfeeding women
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT05924750, who can take part
Where in China
- Beijing HospitalBeijing, ChinaContact: Hui LiuNot yet recruiting
- West China Hospital，Sichuan UniversityChengdu, ChinaContact: Yu WuNot yet recruiting
- Institute of Hematology, the First Hospital of HarbinHaerbin, ChinaContact: Tiejun GongNot yet recruiting
- Anhui Provincial HospitalHefei, ChinaContact: Changcheng ZhengNot yet recruiting
- Qilu Hospital of Shandong UniversityJinan, ChinaContact: Chunyan JiNot yet recruiting
- Shanghai Tongji HospitalShanghai, ChinaContact: Ping LiNot yet recruiting
- Shengjing Hospital Of China Medical UniversityShenyang, ChinaContact: Zhuogang LiuNot yet recruiting
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical SciencesTianjin, ChinaContact: Yali ZhangTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Sichuan Baili Pharmaceutical Co., Ltd.
- Trial code
- NCT05924750
- Record updated
- 26 September 2025
- Original description
Ia: To observe the safety and tolerability of BL-M11D1 in patients with relapsed/refractory acute myeloid leukemia to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of BL-M11D1. Ib: Further observe the safety and tolerability of BL-M11D1 at the recommended dose in phase Ia to determine the recommended dose in phase II clinical study (RP2D).Read full original descriptionShow less
A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BL-M11D1 in Relapsed/Refractory Acute Myeloid Leukemia (AML) Patients
Ia: To observe the safety and tolerability of BL-M11D1 in patients with relapsed/refractory acute myeloid leukemia to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of BL-M11D1. Ib: Further observe the safety and tolerability of BL-M11D1 at the recommended dose in phase Ia to determine the recommended dose in phase II clinical study (RP2D).
Inclusion: Voluntarily sign the informed consent form and comply with the protocol requirements; No gender restrictions; Age: ≥18 years and ≤75 years; Expected survival time ≥3 months; Histologically and/or cytologically confirmed CD33-positive relapsed/refractory acute myeloid leukemia (AML); Morphological assessment showing ≥5% blasts in the bone marrow; ECOG performance status score ≤2; Peripheral blood white blood cell count ≤25×10\^9/L before the first dose; Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0; Organ function levels meet the requirements within 7 days before the first dose; For premenopausal women with childbearing potential, a pregnancy test (serum/urine) must be performed within 7 days before starting treatment, and the result must be negative; they must not be breastfeeding. All enrolled patients (regardless of gender) must use adequate barrier contraception throughout the treatment period and for 6 months after treatment ends.
Exclusion: Antineoplastic therapy, including chemotherapy, biologic therapy, immunotherapy, definitive radiotherapy, major surgery (investigator-defined), or targeted therapy (including small-molecule tyrosine kinase inhibitors), has been administered within 4 weeks or 5 half-life cycles (whichever is shorter) before the first dose; Or palliative radiotherapy within 2 weeks before the first dose; Patients with pulmonary disease grade ≥3 defined by CTCAE v5.0, current or previous interstitial lung disease (ILD); Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT); Had participated in another clinical trial within 4 weeks before the first dose (calculated from the time of last dose); Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory intestinal diseases and Hashimoto's thyroiditis, etc., excluding type I diabetes mellitus, hypothyroidism that can only be controlled by replacement therapy, and skin diseases without systemic treatment (such as vitiligo and psoriasis); Other malignancies diagnosed within 5 years before the first dose, except for radical basal cell carcinoma, squamous cell carcinoma, and/or radical resection carcinoma in situ; Poorly controlled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg); Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of the ingredients of BL-M11D1; Human immunodeficiency virus (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBsAg positive; HBcAb positive and HBV-DNA copy number > lower detection limit) or active hepatitis C virus infection (HCV antibody positive and HCV-RNA > lower detection limit); Active infection requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc; Other conditions for participation in the trial were not considered appropriate by the investigator; History of severe heart disease, such as left ventricular ejection fraction < 50%, history of symptomatic congestive heart failure (CHF) ≥ grade 2 (CTCAE v5.0), New York Heart Association (NYHA) ≥ grade 2 heart failure, history of myocardial infarction, unstable angina, etc; Prolonged QT interval (QTc > 450 msec in men or QTc > 470 msec in women), complete left bundle branch block, and III degree atrioventricular block; Acute promyelocytic leukemia, acute transformation of chronic myeloid leukemia; Patients with central nervous system involvement; Presence of pleural, abdominal, pelvic or pericardial effusion with clinical symptoms or requiring repeated drainage; Pregnant or lactating women.