New antibody takes aim at Hard-to-Treat blood cancers
NCT ID NCT02530034
First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times
Summary
This early-stage trial tests a new antibody drug called Hu8F4 in 72 people with advanced blood cancers like leukemia and myelodysplastic syndrome. The goal is to find the safest dose and see if it can slow or stop cancer growth. Researchers will also track how long patients live and whether their cancer stays away.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Hu8F4 (a monoclonal antibody)
- What this could lead to
- If it works, this could point toward a new treatment option for people with advanced blood cancers that have not responded to other therapies.
- What could go wrong
- This is an early Phase 1 trial with only 72 participants, so it is primarily testing safety and dosing. It may not show strong anti-cancer effects, and side effects are unknown.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2019
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Patients with any of the following diagnoses are eligible: 1) high-risk MDS (i.e. refractory anemia with excess blasts \[RAEB-1 or RAEB-2\] by World Health Organization \[WHO\] classification, or any WHO subset with International Prognostic Scoring System \[IPSS\] intermediate-2 or high, or any patients that have failed prior therapy with hypomethylating agents); 2) chronic myelomonocytic leukemia (CMML); 3) acute myeloid leukemia (AML) by WHO classification; 4) chronic myeloid leukemia in blast phase (CML-BP); 5) myelofibrosis with high-risk features (e.g., accelerated phase disease -10-19% blasts in peripheral blood or bone marrow-, or with Dynamic International Prognostic Scoring System \[DIPSS\]-plus high risk score) * Patients must have relapsed/refractory disease and have failed, or are not candidates for, or have declined all available therapies of proven efficacy; they should also not be eligible for at the time of enrollment or have declined hematopoietic stem cell transplantation * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * The effects of Hu8F4 on a fetus or nursing child are unknown; women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device \[IUD\], oral contraceptive or double barrier device), and must have a negative urine pregnancy test within 2 weeks prior to beginning treatment on this trial; nursing patients are excluded; sexually active men must also use acceptable contraceptive methods for the duration of time on study * Patients must have human leukocyte antigen (HLA)-A2 phenotype * Must be able and willing to give written informed consent * Patients must be at least 2 weeks from prior chemotherapy, radiation therapy, or major surgery, and at least 4 weeks or 5 half lives from other investigational anticancer therapy, and have recovered from prior toxicities at least to grade 1; the exception is hydroxyurea that requires no washout prior to the start of study drug * Clinically significant toxicities from prior chemotherapy must not be greater than grade 1 * Clearance creatinine or glomerular filtration rate (GFR) \>= 40 mL/min * Total bilirubin =\< 1.5 x the upper limit of normal unless considered due to Gilbert's syndrome or leukemic involvement * Alanine aminotransferase (ALT) =\< 3 x the upper limit of normal unless considered due to leukemic involvement Exclusion Criteria: * Uncontrolled intercurrent illness including, but not limited to uncontrolled infection (patients must have no temperature \>= 38.3 degrees Celsius \[C\] due to infection for at least 48 hrs to consider an infection controlled), psychiatric illness that would limit compliance with study requirements, or active heart disease including confirmed myocardial infarction within previous 3 months, symptomatic coronary artery disease, clinically significant arrhythmias not controlled by medication, or uncontrolled congestive heart failure New York (NY) Heart Association class III or IV * Patients with current active malignancies or any remission for \< 18 months, except patients with carcinoma in situ or with non-melanoma skin cancer who may have active disease or be in remission for less than 6 months * Patients receiving any other standard or investigational treatment for their hematologic malignancy other than supportive care * Patients who have had any major surgical procedure within 14 days of day 1 * Patients with known central nervous system infiltration with leukemia * Patients who received an allogeneic stem cell transplant =\< 90 days from the start of therapy * Patients with active \>= grade 3 graft versus host disease (GVHD), or receiving systemic steroids (\> 10 mg/day of prednisone or equivalent) for GVHD * Patients with known active central nervous system (CNS) disease; patients with history of active CNS disease should have at least two negative spinal fluid evaluations before being considered eligible
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Augusta University
Augusta, Georgia, 30912, United States
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Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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Montefiore Medical Center, Albert Einstein College of Medicine
The Bronx, New York, 10467, United States
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