Not yet recruiting NCT07591168
A Study of BL-M11D1 in Patients With Relapsed/Refractory Myelodysplastic Syndromes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BL-M11D1.
- Who it may be relevant to
- Registry conditions: Myelodysplastic Syndromes. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
The study consists of two phases: a dose-exploration phase (Phase Ib) and a dose-expansion phase (Phase II).
Interventions
- Drug BL-M11D1
Administration by intravenous infusion for a cycle of 4 weeks.
Primary outcome measures
- Phase Ib: Recommended Phase II Dose (RP2D) [Time frame: Up to approximately 24 months]
- Phase Ib: Treatment-Emergent Adverse Event (TEAE) [Time frame: Up to approximately 24 months]
- Phase II: Objective Response Rate (ORR) [Time frame: Up to approximately 24 months]
- Phase II: Complete Response (CR) [Time frame: Up to approximately 24 months]
Secondary outcome measures (10)
- Cmax [Time frame: Up to approximately 24 months]
- Tmax [Time frame: Up to approximately 24 months]
- T1/2 [Time frame: Up to approximately 24 months]
- AUC0-t [Time frame: Up to approximately 24 months]
- CL (Clearance) [Time frame: Up to approximately 24 months]
- Ctrough [Time frame: Up to approximately 24 months]
- ADA (anti-drug antibody) [Time frame: Up to approximately 24 months]
- Phase II: Duration of Response (DOR) [Time frame: Up to approximately 24 months]
- Phase II: Hematologic Improvement (HI) [Time frame: Up to approximately 24 months]
- Phase II: AML Transformation Rate [Time frame: Up to approximately 24 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences — Tianjin
Identifiers
NCT: NCT07591168 · BL-M11D1-102