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

NCT06714591 | Recruiting Phase 1 FDA Drug

• 1 other identifier: BL-M11D1-HM-101
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Relapsed/Refractory Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (3)

• 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

  1 Year

• 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)

  1 Year

• 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.

  1 Year

Secondary Outcomes (19)

• Cmax of BL-M11D1

  1 Year

• Tmax of BL-M11D1

  1 Year

• Tmax of free payload ED-04

  1 Year

• Cmax of free payload ED-04

  1 Year

• AUC(0-8) of BL-M11D1

  1 Year

Study Arms (2)

Experimental: Cohort A BL-M11D1 administered Days 1, 8 and 15 in 28-day cycle

EXPERIMENTAL

Cohort A: BL-M11D1 will be administered on Days 1, 8 and 15 by intravenous infusion every 28 days.

Drug: BL-M11D1

Experimental: Cohort B BL-M11D1 administered Days 1, 4 7 or 8 in 28-day cycle

EXPERIMENTAL

Cohort B: BL-M11D1 will be administered on Days 1,4, 7 or 8 by intravenous infusion every 28 days.

Drug: BL-M11D1

Interventions

BL-M11D1 DRUG

The study includes 2 parts: Part 1 Dose escalation and Dose Finding

Experimental: Cohort A BL-M11D1 administered Days 1, 8 and 15 in 28-day cycle; Experimental: Cohort B BL-M11D1 administered Days 1, 4 7 or 8 in 28-day cycle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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
• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• SystImmune Inc.: lead

Study Sites (14)

City of Hope

Duarte, California, 91010, United States

RECRUITING

UCLA Ronald Reagan Medical Center

Los Angeles, California, 90095, United States

RECRUITING

Yale Cancer Center, Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, 06511, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

START Midwest/The Cancer and Hematology Center

Grand Rapids, Michigan, 49546, United States

RECRUITING

Oncology Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, 45236, United States

RECRUITING

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

WVCI Oncology Associates of Oregon

Eugene, Oregon, 24224, United States

RECRUITING

SCRI -TriStar BMT

Nashville, Tennessee, 37203, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Texas Oncology, P.A.

San Antonio, Texas, 78240, United States

RECRUITING

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

RECRUITING

Oncology & Hematology Associates of Southwest Virginia, Inc.

Roanoke, Virginia, 24014, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Loren VanPelt

  SystImmune Inc.

  STUDY DIRECTOR

Central Study Contacts

Loren VanPelt

CONTACT

4254536841; loren.vanpelt@systimmune.com

Whitney Eakins

CONTACT

whitney.eakins@systimmune.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 3, 2024
• Study Start: December 19, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)