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Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)Phase 1NCT05924750

A Study of BL-M11D1 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

A Phase 1 study testing BL-M11D1 in people with Relapsed/Refractory Acute Myeloid Leukemia (R/R AML), run by Sichuan Baili Pharmaceutical Co., Ltd. at 8 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
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
130 participants
Where
8 sitesChina
Study dates
2 Aug 2023to Dec 2027
Phase
Phase 1
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;
  • Histologically and/or cytologically confirmed CD33-positive relapsed/refractory acute myeloid leukemia (AML);
  • Morphological assessment showing ≥5% blasts in the bone marrow;
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  • 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.

Who cannot join

  • Acute promyelocytic leukemia, acute transformation of chronic myeloid leukemia.
  • 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.
  • 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.
  • 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.
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  • Poorly controlled hypertension (systolic blood pressure \&gt; 150 mmHg or diastolic blood pressure \&gt; 100 mmHg).
  • Patients with pulmonary disease grade ≥3 defined by CTCAE v5.0, current or previous interstitial lung disease (ILD).
  • Patients with central nervous system involvement.
  • Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of the ingredients of BL-M11D1.
  • Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT).
  • 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.
  • Presence of pleural, abdominal, pelvic or pericardial effusion with clinical symptoms or requiring repeated drainage.
  • Had participated in another clinical trial within 4 weeks before the first dose (calculated from the time of last dose).
  • Pregnant or lactating women.
  • Other conditions for participation in the trial were not considered appropriate by the investigator.

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sa Xiao, PHD contact

+8615013238943

xiaosa@baili-pharm.com

8 sites in 1 country

China8 sites, 8 recruiting

  • Beijing Hospital

    Beijing, Beijing Municipality

    Hui Liu

    Not yet recruiting

  • West China Hospital，Sichuan University

    Chengdu, Sichuan

    Yu Wu

    Not yet recruiting

  • Institute of Hematology, the First Hospital of Harbin

    Haerbin, Heilongjiang

    Tiejun Gong

    Not yet recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui

    Changcheng Zheng

    Not yet recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shangdong

    Chunyan Ji

    Chunyan Ji

    Not yet recruiting

  • Shanghai Tongji Hospital

    Shanghai, Shanghai Municipality

    Ping Li

    Not yet recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

    Zhuogang Liu

    Not yet recruiting

  • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 300020

    Yali Zhang, 022-23909095, ec@ihcams.ac.cn

    Junyuan Qi

    Recruiting

Other trials in China

About this study

Official title: 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).

Being tested
BL-M11D1
Medical subject headings
Recurrence, Leukemia, Myeloid, Acute

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

Study groups in NCT05924750
Study groupRoleWhat they receive
Study treatmentExperimentalParticipants receive BL-M11D1 as intravenous infusion 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.

  1. Phase Ia: Dose limiting toxicity (DLT)

    DLTs are assessed according to NCI-CTCAE v5.0 during the first cycle and defined as occurrence of any of the toxicities in DLT definition if judged by the investigator to be possibly, probably or definitely related to study drug administration.

    Measured: Up to 28 days after the first dose

  2. Phase Ia: Maximum tolerated dose (MTD)

    MTD is defined as the highest dose level at which no more than 1 in 6 participants experienced a DLT during the first cycle .

    Measured: Up to 28 days after the first dose

  3. 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 28 days after the first dose

Secondary outcomes (11)

  1. 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

  2. Cmax

    Maximum serum concentration (Cmax) of BL-M11D1 will be investigated.

    Measured: Up to 28 days after the first dose

  3. Tmax

    Time to maximum serum concentration (Tmax) of BL-M11D1 will be investigated.

    Measured: Up to 28 days after the first dose

  4. T1/2

    Half-life (T1/2) of BL-M11D1 will be investigated.

    Measured: Up to 28 days after the first dose

  5. 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 28 days after the first dose

  6. CL (Clearance)

    CL in the serum of BL-M11D1 per unit of time will be investigated.

    Measured: Up to 28 days after the first dose

  7. Ctrough

    Ctough is defined as the lowest serum concentration of BL-M11D1 prior to the next dose will be administered.

    Measured: Up to 28 days after the first dose

  8. ADA (anti-drug antibody)

    ADA of BL-M11D1 will be evaluated.

    Measured: Up to approximately 24 months

  9. Phase Ib: 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

  10. Phase Ib: Disease Control Rate (DCR)

    The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]).

    Measured: Up to approximately 24 months

  11. Phase Ib: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2023
  2. Study start2 Aug 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05924750
Sponsor's protocol ID
BL-M11D1-101
Status last verified
Sep 2025
First submitted
16 Jun 2023
Last updated
26 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BL-M11D1 in people with Relapsed/Refractory Acute Myeloid Leukemia (R/R AML), run by Sichuan Baili Pharmaceutical Co., Ltd. at 8 sites 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 11 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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 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.

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 (+8615013238943, 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 Ia: Dose limiting toxicity (DLT) (time frame: Up to 28 days after the first dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05924750.

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 26 Sep 2025.

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