Myelodysplastic SyndromesPhase 1/2NCT07591168
A Study of BL-M11D1 in Patients With Relapsed/Refractory Myelodysplastic Syndromes
A Phase 1/2 study testing BL-M11D1 in people with Myelodysplastic Syndromes, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- BL-M11D1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality
Zhijian Xiao
About this study
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
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 the detailed description
The study consists of two phases: a dose-exploration phase (Phase Ib) and a dose-expansion phase (Phase II).
- Conditions
- Myelodysplastic Syndromes
- Being tested
- BL-M11D1
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL-M11D1Drug
Administration by intravenous infusion for a cycle of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| BL-M11D1 | Experimental | Participants receive BL-M11D1 for the first cycle (4 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. Receives: Drug: BL-M11D1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ib: Recommended Phase II Dose (RP2D)
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-M11D1.
Measured: Up to approximately 24 months
Phase Ib: Treatment-Emergent Adverse Event (TEAE)
TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-M11D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M11D1.
Measured: Up to approximately 24 months
Phase II: Objective Response Rate (ORR)
ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.
Measured: Up to approximately 24 months
Phase II: Complete Response (CR)
Complete Response (CR) is defined as the disappearance of all target lesions, with any pathological lymph nodes (whether target or non-target) having a short axis diameter reduced to <10 mm.
Measured: Up to approximately 24 months
Secondary outcomes (10)
Cmax
Maximum serum concentration (Cmax) of BL-M11D1 will be investigated.
Measured: Up to approximately 24 months
Tmax
Time to maximum serum concentration (Tmax) of BL-M11D1 will be investigated.
Measured: Up to approximately 24 months
T1/2
Half-life (T1/2) of BL-M11D1 will be investigated.
Measured: Up to approximately 24 months
AUC0-t
AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration.
Measured: Up to approximately 24 months
CL (Clearance)
CL in the serum of BL-M11D1 per unit of time will be investigated.
Measured: Up to approximately 24 months
Ctrough
Ctrough is defined as the lowest serum concentration of BL-M11D1 prior to the next dose will be administered.
Measured: Up to approximately 24 months
ADA (anti-drug antibody)
Frequency of anti-BL-M11D1 antibody (ADA) will be investigated.
Measured: Up to approximately 24 months
Phase II: Duration of Response (DOR)
The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.
Measured: Up to approximately 24 months
Phase II: Hematologic Improvement (HI)
HI is defined as achieving a predefined threshold of improvement in the erythroid, platelet, or neutrophil lineages according to the IWG 2006 and IWG 2023 criteria, with a duration of no less than 8 weeks.
Measured: Up to approximately 24 months
Phase II: AML Transformation Rate
The AML transformation rate is defined as the first confirmed event of transformation to acute myeloid leukemia according to WHO criteria (bone marrow blasts ≥20% or presence of extramedullary infiltration).
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by Sichuan Baili Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591168
- Sponsor's protocol ID
- BL-M11D1-102
- Status last verified
- Aug 2026
- First submitted
- 9 May 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07591168
- Acronym / sponsor ID
- BL-M11D1-102
- Conditions
- Myelodysplastic Syndromes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BL-M11D1 | Experimental | Drug: BL-M11D1Participants receive BL-M11D1 for the first cycle (4 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (22 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BL-M11D1Administration by intravenous infusion for a cycle of 4 weeks. | Drug | BL-M11D1 |
Primary outcome
Phase Ib: Recommended Phase II Dose (RP2D)
Time frame: Up to approximately 24 months
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-M11D1.
Phase Ib: Treatment-Emergent Adverse Event (TEAE)
Time frame: Up to approximately 24 months
TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-M11D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M11D1.
Phase II: Objective Response Rate (ORR)
Time frame: Up to approximately 24 months
ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.
Phase II: Complete Response (CR)
Time frame: Up to approximately 24 months
Complete Response (CR) is defined as the disappearance of all target lesions, with any pathological lymph nodes (whether target or non-target) having a short axis diameter reduced to <10 mm.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BL-M11D1 in people with Myelodysplastic Syndromes, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sa Xiao, PHD (15013238943, xiaosa@baili-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ib: Recommended Phase II Dose (RP2D) (time frame: Up to approximately 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.