BL-M11D1 for Myelodysplastic Syndromes That Returned or Did Not Respond to Treatment
Tests BL-M11D1 in adults whose myelodysplastic syndromes came back or resisted earlier treatment.
Plain-language title generated from the registry record
Registry title: A Study of BL-M11D1 in Patients With Relapsed/Refractory Myelodysplastic Syndromes
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 1/2
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: NCT07591168, who can take part
Where in China
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical SciencesTianjin, ChinaNo longer taking part
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?
Trial details
- Who runs it
- Sichuan Baili Pharmaceutical Co., Ltd.
- Trial code
- NCT07591168
- Record updated
- 27 August 2026
- Original description
This study is an open-label, multicenter, non-randomized Phase Ib/II clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of BL-M11D1 for injection in patients with relapsed/refractory myelodysplastic syndromes.Read full original descriptionShow less
A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of BL-M11D1 for Injection in Patients With Relapsed/Refractory Myelodysplastic Syndromes
This study is an open-label, multicenter, non-randomized Phase Ib/II clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of BL-M11D1 for injection in patients with relapsed/refractory myelodysplastic syndromes.
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; Relapsed/refractory CD33+ MDS; Morphological assessment showing blasts in bone marrow ≥5% and <20%; Eastern Cooperative Oncology Group (ECOG) performance status ≤2; Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0; Meet the required organ function levels; For premenopausal women of childbearing potential, a pregnancy test (serum/urine) must be negative within 7 days before starting treatment, and they must not be breastfeeding; all enrolled trial participants (regardless of gender) must practice adequate barrier contraception throughout the entire treatment period and for 6 months after treatment completion.
Exclusion: Use of chemotherapy, biotherapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose; Thromboembolic events requiring therapeutic intervention within 6 months prior to screening; Diagnosis of another malignancy within 5 years prior to the first dose; Prior organ transplantation or hematopoietic stem cell transplantation; Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent; Participation in another clinical trial within 4 weeks or 5 half-lives prior to the first dose; History of severe cardiovascular or cerebrovascular disease; Active autoimmune diseases and inflammatory diseases; History of extensive bowel resection or presence of Crohn's disease, ulcerative colitis, chronic diarrhea, or intestinal obstruction; Poorly controlled hypertension; Poorly controlled hyperglycemia or diabetes mellitus; Pulmonary diseases classified as Grade ≥3 according to CTCAE v6.0, etc; Trial participants with a history of allergy to recombinant humanized antibodies or chimeric human-mouse antibodies, or hypersensitivity to any excipient component of BL-M11D1; Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection; Active fungal, bacterial, or viral infections; History of severe neurological or psychiatric disorders; Other conditions deemed by the investigator to make the participant unsuitable for participation in this clinical trial; Presence of uncorrected folate deficiency or vitamin B12 deficiency, etc; Trial participants with central nervous system involvement; Trial participants with extramedullary involvement; Presence of clinically symptomatic pleural, peritoneal, or pericardial effusion requiring repeated drainage; Pregnant or breastfeeding women.