Experimental antibody may boost leukemia treatment

NCT ID NCT06384261

Disease control Sponsor: OncoVerity, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether adding an experimental antibody called cusatuzumab to the standard drugs venetoclax and azacitidine helps people with newly diagnosed acute myeloid leukemia (AML) live longer. The study includes 140 adults who cannot have intensive chemotherapy. Participants are randomly assigned to receive either the three-drug combination or the standard two drugs alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: cusatuzumab (an experimental antibody) added to venetoclax and azacitidine
What this could lead to: If it works, this could lead to a new treatment option that helps people with AML live longer without needing intensive chemotherapy.
What could go wrong: This is an early phase 2 trial with only 140 participants, so results may not apply to everyone. Adding cusatuzumab could also increase side effects without improving survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Men and women ≥18 years old * Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for the study and is willing to participate in the study * Diagnosis of AML according to ICC 2022 (with the exclusion of MDS/AML with 10-19% blasts) * Previously untreated AML except may have received emergency leukapheresis, hydroxyurea before study entry to control hyperleukocytosis * Deemed unfit for intensive chemotherapy by meeting at least 1 of the following criteria: 1. Participant is ≥75 years of age with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 OR 2. Participant is ≥18 to 74 years of age and has any of the following comorbidities: 1. ECOG performance status of 2 or 3 2. Cardiac status including any one of the following: congestive heart failure requiring treatment or ejection fraction ≤50% or chronic stable angina 3. Known history of diffusion capacity of lung for carbon monoxide (DLCO) ≤65% of forced expiratory volume in the first second (FEV1) ≤65% 4. Creatinine clearance (CrCl) ≥15 mL/min to \<45 mL/min 5. Hepatic disorder with total bilirubin \>1.5 to 3x the upper limit of normal (ULN) 6. Any other comorbidity that the investigators determine to be incompatible with conventional intensive chemotherapy * Adequate liver and renal function defined as: 1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<3xULN; for participants with leukemic infiltration of the liver (documented by biopsy or imaging), AST and ALT \<5xULN is permitted 2. Total bilirubin ≤1.5xULN, unless bilirubin rise is due to Gilbert's syndrome or of nonhepatic origin. Participants who are \<75 years of age may have a bilirubin up to 3xULN. 3. Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 (by the Modification of Diet in Renal Disease \[MDRD\] formula). Participants who are \<75 years of age may have an eGFR ≥15 mL/min/1.73 m2. * Women of childbearing potential (WOCBP), defined as fertile women between menarche and post menopause unless permanently sterile, must have a negative highly sensitive serum β-human chorionic gonadotropin (β-hCG) or urine pregnancy test at screening * Must be willing to use contraception as consistent with institutional guidelines regarding the use of contraceptive methods for participants participating in clinical studies 1. WOCBP must agree to adhere to the following birth control measures while receiving study treatment continuing to 3 months after the last dose of study drug: 1. Must be practicing a highly effective method of birth control (failure rate of \<1% per year when used consistently and correctly) as determined by institutional standards 2. Must agree to not donate eggs (ova, oocytes) for the purposes of assisted reproduction 3. Must not be breastfeeding and not planning to become pregnant 2. Male participants who are sexually active with WOCBP, and male partners of study participants who are WOCBP, and who are not surgically or otherwise sterile must agree to adhere to the following birth control measures while receiving study treatment and for 3 months after the last dose of study drug: 1. Must agree to use a barrier method of birth control (e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap \[diaphragm or cervical/vault caps\] with spermicidal foam, gel, film, cream, or suppository) 2. Must not donate sperm 3. Must no plan to father a child * Participants with HIV infection are eligible for the trial if the following criteria are met: 1. CD4+ T-cell count ≥200 cells/μL 2. No prior history of AIDS-defining opportunistic infection within the past 12 months 3. Receiving treatment with antiretroviral therapy 4. Undetectable viral load within 6 months of screening Exclusion Criteria: * Any prior treatment for AML (except those outlined in inclusion criterion #4) * Participant has received a hypomethylating agent (HMA) or venetoclax for MDS or myeloproliferative neoplasm * Leukemic involvement in the central nervous system * Participants with acute promyelocytic leukemia (APL) * ECOG performance status of 4 for participants 18 to 74 years of age and ECOG performance status of 3 or 4 for participants ≥75 years of age * Use of immune suppressive agents ≤4 weeks before the first administration of cusatuzumab. Participants may be included if free of systemic corticosteroids \>5 days before the first administration of cusatuzumab with the exception of corticosteroids at physiologic replacement doses. * Received a live, attenuated vaccine within 4 weeks prior to initiation of study drug * Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. Exceptions to this exclusion criterion include the following: 1. Nonmelanoma skin cancer treated within the last 24 months that is considered completely cured 2. Adequately treated breast lobular carcinoma in situ and breast ductal carcinoma in situ 3. Adequately treated cervical carcinoma in situ and breast ductal carcinoma in situ 4. History of localized breast cancer and receiving anti-hormonal agents, or history of localized prostate cancer (N0M0) and receiving androgen depravation therapy 5. A malignancy that is considered cured with minimal risk of recurrence * Any active systemic infection * History of prior HSCT (allogeneic or autologous transplants) * Active hepatitis B or C infection or other clinically active liver diseases ad defined below: 1. Seropositivity for hepatitis B is defined by a positive test for hepatitis B surface antigen (HBsAg) 2. Participants with resolved infection (i.e., participants who are HBsAg negative with antibodies to total hepatitis B core antigen \[anti-HBc\] with or without the presence of hepatitis B surface antibody \[anti-HBs\]) must be screened using PCR measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. * Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR 3. Active hepatitis C infection as defined by being positive for a nucleic acid test for hepatitis C virus (HCV) RNA * Congestive hear failure severity that is New York Heart Association Class III or IV * Unstable angina * Known allergies, hypersensitivity, or intolerance to cusatuzumab, venetoclax, or azacitidine or their excipients (e.g., mannitol, an excipient of azacitidine) * Inability or difficulty swallowing capsules/tablets, malabsorption syndrome, or any disease or medical condition significantly affecting gastrointestinal function * Any condition for which, in the investigator's opinion, participation would not be in the best interest of the participant (e.g., compromise the well-being) or physical limitations that could prevent, limit, or confound the protocol-specified assessments * Major surgery (e.g., requiring general anesthesia) ≤4 weeks prior to initiation of study treatment

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Leukemia, myeloid, acute

Contacts and locations

Locations

AdventHealth Medical Group Blood & Marrow Transplant at Orlando

Orlando, Florida, 32804, United States
Banner MD Anderson

Gilbert, Arizona, 85234, United States
City of Hope

Duarte, California, 91010, United States
Cleveland Clinic - Taussig Cancer Institute

Cleveland, Ohio, 44195, United States
Cornell University

New York, New York, 10065, United States
Fred Hutch Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States
HFR Fribourg - Hopital Cantonal

Fribourg, Switzerland, Switzerland
Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States
Hofstra/Northwell Health

Lake Success, New York, 11042, United States
Hospital De La Santa

Barcelona, Spain
Hospital Universitario de Salamanca

Salamanca, Spain
Inselspital Bern

Bern, 3010, Switzerland
Instituto Catalan de Oncologia - Hospital Duran i Reynals

Barcelona, Spain
Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland
Marien Hospital Duesseldorf

Düsseldorf, 40479, Germany
Medical College of Wisonsin

Milwaukee, Wisconsin, 53226, United States
Medical University of South Carolina

Charleston, South Carolina, 29425, United States
Norton Healthcare, Inc.

Louisville, Kentucky, 40202, United States
Princess Margaret Cancer Centre

Toronto, Ontario, M5F 2M9, Canada
Saskatchewan Cancer Agency - Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N4H4, Canada
Stollery Children's Hospital-Walter C Mackenzie Health Sciences Centre - University of Alberta

Edmonton, Alberta, T6G 2B7, Canada
The Ottawa Hospital - General Campus

Ottawa, Ontario, K1H8L6, Canada
The University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States
Tom Baker Cancer Center-Alberta Health Services - University of Calgary

Calgary, Alberta, T2N 4N2, Canada
Universidad de Navarra - Clinica Universidad de Navarra

Pamplona, Spain
Universitaetsklinik Frankfurt

Frankfurt, 60560, Germany
Universitaetsklinik um Schleswig-Holstein, UKSH-Campus Kiel

Kiel, 24105, Germany
University of California Los Angeles

Los Angeles, California, 90095, United States
University of Colorado Health - Anschutz Cancer Pavilion - Anschutz Medical Campus

Aurora, Colorado, 80045, United States
University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536, United States
University of Miami - Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States
University of Rochester Medical Center

Rochester, New York, 14642, United States
University of South Florida = Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States
University of Western Ontario

London, Ontario, N6A5W9, Canada
Vall d'Hebron Institute of Oncology

Barcelona, Spain
Vancouver General Hospital, Gordon and Leslie Diamond Health Care Centre

Vancouver, British Columbia, V5Z 1M9, Canada
Wake Forest North Carolina

Winston-Salem, North Carolina, 27157, United States
Yale School of Medicine

New Haven, Connecticut, 06510, United States

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