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Relapsed/Refractory Acute Myeloid LeukemiaPhase 1NCT06714591

Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Efficacy of Bl-M11D1

A Phase 1 study testing BL-M11D1 in people with Relapsed/Refractory Acute Myeloid Leukemia, run by SystImmune Inc. at 18 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The objective of this study to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of BL-M11D1 in patients with relapsed/refractory acute myeloid leukemia. Read more about this study

Who is it for?
Ages 18 years and older
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
52 participants
Where
18 sitesUnited States
Study dates
19 Dec 2024to 16 Sep 2026
Phase
Phase 1
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed the informed consent
  • Age ≥18 years
  • Has a life expectancy of ≥3 months
  • Relapsed and/or refractory CD33-positive AML as determined by local pathology review that has failed initial standard of care therapy. Diagnosis of primary AML or AML secondary to myelodysplastic syndromes. Relapsed or refractory status. CD33-positive as confirmed by local flow cytometry or cytology
  • Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2
  • Toxicity of previous anticancer therapy has returned to Grade ≤1 as defined by NCI CTCAE V5.0, except for alopecia and endocrinopathies controlled by replacement therapy that must be Grade ≤2
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  • Has adequate liver and renal function before registration, defined as: a. Hepatic function: Total bilirubin (TBIL) ≤1.5×ULN (≤3×ULN for subjects with Gilbert's syndrome), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN b. Renal function: Creatinine clearance ≥50 mL/min (Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration [CKD-Epi], or Modification of Diet in Renal Disease Study [MDRD] equations)
  • Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception during the course of the study and for 7 months after the last dose of study treatment. An additional contraceptive method, such as a barrier method (eg, condom), is recommended
  • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and must be nonlactating

Who cannot join

  • Subjects with acute promyelocytic leukemia (APL) or chronic myelogenous leukemia in blast crisis (CML)
  • Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other anticancer therapy within 2 weeks) prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration, or palliative radiotherapy within 2 weeks prior to the first administration
  • Subjects with history of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ Grade 2 (CTCAE 5.0), New York Heart Association (NYHA) ≥ Grade 2 heart failure, history of transmural myocardial infarction, unstable cardiac arrhythmias or angina pectoris within 6 months before screening
  • Subjects with prolonged QT interval (QTcF >470 msec), complete left bundle branch block, Grade 3 atrioventricular block or a history of additional risk factors for Torsades de Pointes (TdP; eg, heart failure as defined in Exclusion Criterion 3, chronic or recurrent hypokalemia that requires medical intervention, congenital long QT syndrome, family history of long QT syndrome) or any current concomitant medication known to prolong the QT/QTc interval or cause TdP
  • Active autoimmune diseases and inflammatory diseases, such as: systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease and Hashimoto's thyroiditis, etc., except for Type I diabetes, hypothyroidism that can be controlled only by standard of care treatment, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis)
  • Subjects with other prior or concurrent malignancies except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ after adequate resection, or other malignancy treated with curative intent with as disease-free interval of at least 1 year
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  • Subjects with poorly controlled hypertension or uncontrolled hypertension by two or more antihypertensive drugs (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg)
  • Subjects with active acute or chronic graft vs. host disease (aGVHD or cGVHD) should be excluded from this study. Subjects with GVHD who are receiving treatment with systemic glucocorticoids >10 mg/day equivalent of prednisone should also be excluded from the study; however, treatment with low-dose glucocorticoids (≤10 mg/day equivalent of prednisone) is permitted
  • Subjects currently receiving immunosuppressive therapy should be excluded from this study.
  • Clinical evidence of disseminated intravascular coagulation (DIC). Smoldering low grade DIC is allowed after discussion with the sponsor
  • Subjects with stroke or transient ischemic attack (TIA) within 6 months before screening
  • Subjects with a thromboembolic event (eg, deep vein thrombosis [DVT] or pulmonary embolism [PE]) within 6 months before screening except for those who are clinically stable and receiving treatment with adequate anticoagulant therapy for at least 3 weeks before screening
  • Subjects with active central nervous system (CNS) AML will be excluded. A lumbar puncture does not need to be performed unless there is clinical suspicion of CNS involvement per investigator judgment. Concurrent therapy for CNS prophylaxis or continuation of therapy for controlled CNS AML is allowed with the approval of the sponsor
  • Subjects with pre-existing ≥Grade 2 peripheral neuropathy
  • Subjects with advanced/ clinically significant lung diseases, such as poorly controlled COPD and asthma, restrictive lung disease, pulmonary hypertension etc.
  • Subjects who have a history of noninfectious interstitial lung disease (ILD)/ pneumonitis that required treatment with steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
  • Subjects who have a history of anaphylaxis or severe hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies or any of the components of BL-M11D1
  • Subjects with known human immunodeficiency virus infection (HIV Ab positive) Subjects are allowed to participate if all of the following criteria are met: (1) Undetectable HIV RNA and CD4 count ≥350 cells/μL at screening, (2) No AIDS defining opportunistic infection within 12 months prior to screening, (3) On stable antiretroviral therapy (ART) for at least 4 weeks prior to screening with projected continuation of ART as clinically indicated while on the study
  • Subjects with active Hepatitis B virus (HBV) infection (positive HBsAg test). Subjects with chronic inactive HBV infection are eligible if they meet all of the following criteria:
  • Have a HBV DNA viral load ≤ 500 IU/mL
  • Have normal AST and ALT, OR if liver involvement is present, has AST and ALT <3 × ULN which are not attributed to HBV infection
  • on antiviral treatment, as clinically indicated
  • Subjects with active Hepatitis C virus (HCV) infection (HCV antibody positive and HCV-RNA > the lower limit of detection). Subjects with a positive anti-HCV antibody are eligible only if PCR is negative for HCV RNA
  • Subjects with active or latent tuberculosis
  • Subjects with active and uncontrolled infections requiring IV antibiotic, antiviral, or antifungal treatment, such as severe pneumonia, bacteremia, sepsis, etc., within 1 week prior to first dose of study treatment. Subjects on stable oral antimicrobials with no clinical or laboratory evidence of active infection are eligible
  • Received an investigational drug within 2 weeks prior to first dose of study treatment.
  • Subjects who are pregnant, breastfeeding, or planning to become pregnant during the study
  • Prior treatment with a topoisomerase inhibitor-based antibody-drug conjugate (ADC.)
  • Previous history of significant gastrointestinal conditions, including Grade 3 or higher diarrhea, colitis, gastrointestinal bleeding and history of major gastrointestinal surgeries
  • 28. Progressed on more than 2 different lines of systemic cytotoxic therapies; patients with 3 prior lines of systemic cytotoxic therapy or with prior allogeneic stem cell transplant may be enrolled upon consultation and approval from the sponsor

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21287

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Oncology Hematology Care Clinical Trials, LLC

    Cincinnati, Ohio, 45236

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • City of Hope

    Duarte, California, 91010

  • WVCI Oncology Associates of Oregon

    Eugene, Oregon, 24224

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • START Midwest/The Cancer and Hematology Center

    Grand Rapids, Michigan, 49546

  • John Theurer Cancer Center-Hackensack

    Hackensack, New Jersey, 07601

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • UCLA Ronald Reagan Medical Center

    Los Angeles, California, 90095

  • SCRI -TriStar BMT

    Nashville, Tennessee, 37203

  • Yale Cancer Center, Smilow Cancer Hospital at Yale New Haven

    New Haven, Connecticut, 06511

  • Temple Health Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Multicenter, Open-Label Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of BL-M11D1 in Patients With Relapsed/Refractory Acute Myeloid Leukemia.

The objective of this study to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of BL-M11D1 in patients with relapsed/refractory acute myeloid leukemia.

Read the detailed description

BL-M11D1-HM-101 is a multi-center, Phase 1 study to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of BL-M11D1 in patients with relapsed/refractory acute myeloid leukemia.

This study will be conducted in two parts (dose escalation, and dose finding). Cohort A will be dosed on Days 1, 8,15 of a continuous 28-day treatment cycle. The cohort has different dose groups. Cohort B will be dosed on Days 1, 4, 7 or 8 of a continuous 28-day treatment cycle. The cohorts have different dose groups.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BL-M11D1Drug

    The study includes 2 parts:

    Part 1 Dose escalation and Dose Finding

Study groups in NCT06714591
Study groupRoleWhat they receive
Experimental: Cohort A BL-M11D1 administered Days 1, 8 and 15 in 28-day cycleExperimentalCohort A: BL-M11D1 will be administered on Days 1, 8 and 15 by intravenous infusion every 28 days.
Receives: Drug: BL-M11D1
Experimental: Cohort B BL-M11D1 administered Days 1, 4 7 or 8 in 28-day cycleExperimentalCohort B: BL-M11D1 will be administered on Days 1,4, 7 or 8 by intravenous infusion every 28 days.
Receives: Drug: BL-M11D1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participants with dose-limiting toxicities

    DLTs are defined as any of the following events that are not clearly due to the underlying disease, disease progression, or extraneous causes:

    • Any treatment-emergent adverse event (TEAE) of ≥ Grade 3 except those due to disease progression or extraneous cause
    • Any TEAE that leads to dose reduction or withdrawal Nonhematologic toxicities
    • Death
    • Hy's law cases
    • Grade ≥3 nonhematologic toxicities (with exceptions) Hematologic toxicity
    • Grade 4 thrombocytopenia or neutropenia lasting >42 days in the absence of persistent leukemia
    • Grade ≥3 platelet count decreased with clinically significant hemorrhage

    Measured: 1 Year

  2. Participants with Serious Adverse Events (SAEs) and treatment-emergent adverse events (TEAEs)

    Measuring the number of patients with serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)

    Measured: 1 Year

  3. To determine the minimum safe and effective dose (MSED), maximum tolerated dose (MTD) if reached, and maximum administered dose (MAD) of BL-M11D1 in AML

    Determine the highest BL-M11D1 dose level at which ≤33% subjects experience a DLT during the DLT evaluation period and highest BL-M11D1 dose administered in the event and MTD cannot be defined.

    Measured: 1 Year

Secondary outcomes (19)

  1. Cmax of BL-M11D1

    Calculate maximum (peak) observed concentration of BL-M11D1

    Measured: 1 Year

  2. Tmax of BL-M11D1

    Calculate time of maximum observed concentration of BL-M1D1

    Measured: 1 Year

  3. Tmax of free payload ED-04

    Calculate time of maximum observed concentration of free payload ED-04

    Measured: 1 Year

  4. Cmax of free payload ED-04

    Calculate maximum (peak) observed concentration of free payload ED-04

    Measured: 1 Year

  5. AUC(0-8) of BL-M11D1

    Calculate area under the serum concentration-time curve of BL-M11D1 from time 0 to 8 hours

    Measured: 1 Year

  6. AUC(0-8) of free payload ED-04

    Calculate area under the serum concentration-time curve of free payload ED-04 from time 0 to 8 hours

    Measured: 1 Year

  7. AUC(last) of BL-BM11D1

    Calculate area under the serum concentration-time curve up of BL-M11D1 to the last quantifiable time

    Measured: 1 Year

  8. AUC(last) of free payload ED-04

    Calculate area under the serum concentration-time curve up of free payload ED-04 to the last quantifiable time

    Measured: 1 Year

  9. Tmax of anti-CD33 antibody

    Calculate time of maximum observed concentration of anti-CD33 antibody

    Measured: 1 Year

  10. AUC (0-8) of anti-CD33 antibodies

    Calculate area under the serum concentration-time curve of anti-CD33 antibodies from time 0 to 8 hours

    Measured: 1 Year

  11. AUC (last) anti-CD33 antibodies

    Calculate area under the serum concentration-time curve up of anti-CD33 antibodies to the last quantifiable time

    Measured: 1 Year

  12. Overall Response Rate (ORR)

    To assess the clinical efficacy of BL-M11D1 as measured by ORR using RECIST criteria v 1.1

    Measured: 1 Year

  13. Duration of response (DOR)

    To access the clinical efficacy of BL-M11D1 as measured by DOR using RECIST criteria 1.1

    Measured: 1 Year

  14. Complete Remission (CR)

    To assess the anti-cancer activity of BL-M11D1 as measured by CR using the European LeukemiaNet (ELN) 2022 AML criteria.

    Measured: 1 Year

  15. CR with partial hematologic recovery (CRh)

    To assess the anti-cancer activity of BL-M11D1 as measured by CR using the European LeukemiaNet (ELN) 2022 AML criteria.

    Measured: 1 Year

  16. CR with incomplete hematologic recovery (CRi)

    To assess the anti-cancer activity of BL-M11D1 as measured by CR using the European LeukemiaNet (ELN) 2022 AML criteria.

    Measured: 1 Year

  17. CR/CRi, CRs with or without measurable residual disease (MRD)

    To assess the anti-cancer activity of BL-M11D1 as measured by CR using the European LeukemiaNet (ELN) 2022 AML criteria.

    Measured: 1 Year

  18. morphologic leukemia-free state (MLFS)

    To assess the anti-cancer activity of BL-M11D1 as measured by CR using the European LeukemiaNet (ELN) 2022 AML criteria.

    Measured: 1 Year

  19. partial remission (PR)

    To assess the anti-cancer activity of BL-M11D1 as measured by CR using the European LeukemiaNet (ELN) 2022 AML criteria.

    Measured: 1 Year

Timeline

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

  1. First posted3 Dec 2024
  2. Study start19 Dec 2024
  3. Primary completion16 Sep 2026
  4. Study completion16 Sep 2026

Why it stopped: Sponsor prioritization of other development portfolio

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
Non-randomised
Intervention model
Sequential
Model description
This is a multicenter, open-label Phase 1 study to evaluate the safety, tolerability, pharmacokinetic profile, and initial efficacy of BL-M11D1 in subjects with relapsed/refractory acute myeloid leukemia (r/r AML). This study has two parts: Part 1: Dose Escalation Part 2: Dose Finding
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06714591
Sponsor's protocol ID
BL-M11D1-HM-101
Status last verified
Sep 2026
First submitted
27 Nov 2024
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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, run by SystImmune Inc. at 18 sites in United States.

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 9 inclusion and 30 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: stopped early, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. 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?

The study was stopped early (reason given: Sponsor prioritization of other development portfolio). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants with dose-limiting toxicities (time frame: 1 Year). 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 NCT06714591.

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 24 Sep 2026.

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