A Study of BL-M11D1 in Patients With Relapsed/Refractory Myelodysplastic Syndromes
Starting soon · Phase 1/Phase 2
Conditions studied: Myelodysplastic Syndromes
In brief
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.
Key facts
- Study ID
- NCT07591168
- Run by
- Sichuan Baili Pharmaceutical Co., Ltd.
- People needed
- 92
- Starts
- 2026-05-01
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-05-15
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Use of chemotherapy, biotherapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;
- Presence of uncorrected folate deficiency or vitamin B12 deficiency, etc.;
- History of severe cardiovascular or cerebrovascular disease;
- Thromboembolic events requiring therapeutic intervention within 6 months prior to screening;
- Active autoimmune diseases and inflammatory diseases;
- History of extensive bowel resection or presence of Crohn's disease, ulcerative colitis, chronic diarrhea, or intestinal obstruction;
- Diagnosis of another malignancy within 5 years prior to the first dose;
- Poorly controlled hypertension;
- Poorly controlled hyperglycemia or diabetes mellitus;
- Pulmonary diseases classified as Grade ≥3 according to CTCAE v6.0, etc.;
- Trial participants with central nervous system involvement;
- Trial participants with extramedullary involvement;
- 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;
- Prior organ transplantation or hematopoietic stem cell transplantation;
- 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;
- Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent;
- Presence of clinically symptomatic pleural, peritoneal, or pericardial effusion requiring repeated drainage;
- Participation in another clinical trial within 4 weeks or 5 half-lives prior to the first dose;
- Pregnant or breastfeeding women;
- Other conditions deemed by the investigator to make the participant unsuitable for participation in this clinical trial.
Where it is running
- Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences — Tianjin, Tianjin Municipality, China
Full record on ClinicalTrials.gov
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