Actively Recruiting
Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Efficacy of Bl-M11D1
Led by SystImmune Inc. · Updated on 2025-12-31
120
Participants Needed
14
Research Sites
118 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Efficacy of Bl-M11D1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed the informed consent
- Age 18 years or older
- Life expectancy of at least 3 months
- Relapsed or refractory CD33-positive acute myeloid leukemia confirmed by local pathology
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Previous anticancer therapy toxicity recovered to Grade 1 or lower, except controlled alopecia and endocrinopathies which can be Grade 2 or lower
- Adequate liver function: total bilirubin ≤1.5× upper limit of normal (ULN), or ≤3× ULN if Gilbert's syndrome; AST and ALT ≤2.5× ULN
- Adequate kidney function: creatinine clearance ≥50 mL/min calculated by standard equations
- Sexually active fertile participants and partners must agree to use effective contraception during the study and for 7 months after last dose; additional barrier method recommended
- Women of childbearing potential must have a negative pregnancy test at screening and must not be breastfeeding
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia or chronic myelogenous leukemia in blast crisis
- Received chemotherapy, biological therapy, immunotherapy, radiotherapy, major surgery, targeted therapy, or other anticancer treatment within 2 weeks prior to first dose (mitomycin and nitrosoureas within 6 weeks)
- History of severe heart disease including symptomatic congestive heart failure Grade 2 or higher, recent myocardial infarction, unstable arrhythmias or angina within 6 months
- Prolonged QT interval, bundle branch block, severe atrioventricular block, or other risk factors for Torsades de Pointes
- Active autoimmune or inflammatory diseases requiring systemic treatment except controlled diabetes, hypothyroidism, or mild skin diseases
- Other prior or current malignancies except certain skin cancers or cancers treated with curative intent and disease-free for at least 1 year
- Poorly controlled hypertension despite two or more medications
- Active acute or chronic graft versus host disease or on high-dose systemic glucocorticoids
- Current immunosuppressive therapy
- Evidence of disseminated intravascular coagulation except stable low-grade cases
- Recent stroke, transient ischemic attack, or thromboembolic events within 6 months unless stable on anticoagulants
- Active central nervous system AML unless controlled with sponsor approval
- Pre-existing Grade 2 or higher peripheral neuropathy
- Significant lung diseases such as uncontrolled COPD, asthma, restrictive lung disease, or pulmonary hypertension
- History or presence of interstitial lung disease or pneumonitis requiring steroids
- History of severe allergic reactions to humanized or chimeric antibodies or BL-M11D1 components
- Known HIV infection unless well-controlled with stable therapy and no recent opportunistic infections
- Active Hepatitis B or C infections except well-controlled cases meeting specific criteria
- Active or latent tuberculosis
- Active uncontrolled infections requiring intravenous antimicrobial treatment within 1 week prior to first dose
- Participation in other investigational drug studies within 2 weeks prior to first dose
- Pregnant, breastfeeding, or planning pregnancy during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
UCLA Ronald Reagan Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
3
Yale Cancer Center, Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States, 06511
Actively Recruiting
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
5
START Midwest/The Cancer and Hematology Center
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
6
Oncology Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, United States, 45236
Actively Recruiting
7
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
8
WVCI Oncology Associates of Oregon
Eugene, Oregon, United States, 24224
Actively Recruiting
9
SCRI -TriStar BMT
Nashville, Tennessee, United States, 37203
Actively Recruiting
10
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
11
Texas Oncology, P.A.
San Antonio, Texas, United States, 78240
Actively Recruiting
12
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
13
Oncology & Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, United States, 24014
Actively Recruiting
14
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Not Yet Recruiting
Research Team
L
Loren VanPelt
CONTACT
W
Whitney Eakins
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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