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Tests treatment safety and results for Relapsed/Refractory Acute Myeloid Leukemia
Official title Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Efficacy of Bl-M11D1
ClinicalTrials.gov ID: NCT06714591
What this study is testing
What is BL-M11D1?
BL-M11D1 is an investigational medicine, being studied as a potential treatment for relapsed/refractory acute myeloid leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2
You likely can't join if
- people 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...
- people with history of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ Grade 2 (CTCAE 5.0), New York Heart Association...
- people with prolonged QT interval (QTcF \>470 msec), complete left bundle branch block, Grade 3 atrioventricular block or a history of additional...
- Active autoimmune diseases and inflammatory diseases, such as: systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid...
- people with other prior or concurrent malignancies except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma...
See the full eligibility criteria
Who can 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...
- 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
- Has adequate liver and renal function before registration, defined as: a. Hepatic function: Total bilirubin (TBIL) ≤1.5×ULN (≤3×ULN for people with Gilbert's syndrome), aspartate aminotransferase (AST) and alanine...
- Sexually active fertile people 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...
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and must be nonlactating
What rules you out
- people 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...
- people 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...
- people 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...
- 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...
- people 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...
- people with poorly controlled hypertension or uncontrolled hypertension by two or more antihypertensive drugs (systolic blood pressure \>150 mmHg or diastolic blood pressure \>100 mmHg)
- people with active acute or chronic graft vs. host disease (aGVHD or cGVHD) should be excluded from this study. people with GVHD who are receiving treatment with systemic glucocorticoids \>10 mg/day equivalent of...
- people 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
- people with stroke or transient ischemic attack (TIA) within 6 months before screening
- people 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...
- people 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...
- people with pre-existing ≥Grade 2 peripheral neuropathy
- people with advanced/ clinically significant lung diseases, such as poorly controlled COPD and asthma, restrictive lung disease, pulmonary hypertension etc.
- people 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...
- people 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
- people with known human immunodeficiency virus infection (HIV Ab positive) people are allowed to participate if all of the following criteria are met: (1) Undetectable HIV RNA and CD4 count ≥350 cells/μL at screening...
- people with active Hepatitis B virus (HBV) infection (positive HBsAg test). people 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
- people with active Hepatitis C virus (HCV) infection (HCV antibody positive and HCV-RNA \> the lower limit of detection). people with a positive anti-HCV antibody are eligible only if PCR is negative for HCV RNA
- people with active or latent tuberculosis
- people 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...
- Received an investigational drug within 2 weeks prior to first dose of study treatment.
- people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Los Angeles, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Grand Rapids, Michigan, United States
- Hackensack, New Jersey, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Eugene, Oregon, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Fairfax, Virginia, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Los Angeles, California, United States; Aurora, Colorado, United States; New Haven, Connecticut, United States; Tampa, Florida, United States; Chicago, Illinois, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.