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Active, not recruitingNCT02530034Updated Sep 18, 2026

Hu8F4 in Treating Patients With Advanced Hematologic Malignancies

A Phase 1 interventional study of Anti-PR1/HLA-A2 Monoclonal Antibody Hu8F4 and Laboratory Biomarker Analysis in Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by M.D. Anderson Cancer Center. Active, not recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by M.D. Anderson Cancer Center · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
72
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This phase I trial studies the side effects and best dose of anti-PR1/HLA-A2 monoclonal antibody Hu8F4 (Hu8F4) in treating patients with malignancies related to the blood (hematologic). Monoclonal antibodies, such as Hu8F4, may interfere with the ability of cancer cells to grow and spread.

Read the detailed description

PRIMARY OBJECTIVES:

I. To determine the dose limiting toxicity (DLT) and minimum safe and biologically-effective dose of Hu8F4 when administered intravenously in patients with leukemia or myelodysplastic syndrome (MDS).

II. To determine the pharmacokinetics (PK) of Hu8F4 following study drug administration.

SECONDARY OBJECTIVES:

I. To observe the anti-leukemia effects of Hu8F4 in patients with leukemias and MDS.

II. To measure the overall survival, disease-free survival and event-free survival of patients with leukemias or MDS treated with Hu8F4.

OUTLINE: This is a dose-escalation study.

Patients receive anti-PR1/HLA-A2 monoclonal antibody Hu8F4 intravenously (IV) over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

02

Conditions studied

  • Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
  • Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Hematopoietic and Lymphoid Cell Neoplasm
  • High Risk Myelodysplastic Syndrome
  • Myelodysplastic Syndrome With Excess Blasts-1
  • Myelodysplastic Syndrome With Excess Blasts-2
  • Myelofibrosis
  • Recurrent Acute Myeloid Leukemia
  • Recurrent Chronic Myelomonocytic Leukemia
  • Refractory Chronic Myelomonocytic Leukemia
  • Secondary Acute Myeloid Leukemia
03

In context

Blast Crisis

137 studies on the registry are indexed under Blast Crisis; 13 are open to participants now.

This study's planned enrollment of 72 is above the median of 35 across 117 interventional studies indexed under Blast Crisis.

Browse Blast Crisis studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    Treatment (Hu8F4)

    Patients receive anti-PR1/HLA-A2 monoclonal antibody Hu8F4 IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

    Drug: Anti-PR1/HLA-A2 Monoclonal Antibody Hu8F4 · Other: Laboratory Biomarker Analysis · Other: Pharmacological Study

Interventions

  • DrugAnti-PR1/HLA-A2 Monoclonal Antibody Hu8F4

    Given IV

    Also known as: Hu8F4

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • OtherPharmacological Study

    Correlative studies

06

What researchers measure

Primary outcomes

  1. Minimum safety data

    Safety data will be summarized using frequency and percentage for all patients.

    Time frame: 4 weeks

  2. Biologically-effective dose

    Safety data will be summarized using frequency and percentage for all patients.

    Time frame: 4 weeks

Secondary outcomes

  1. Overall survival

    Estimated using the Kaplan-Meier methods.

    Time frame: Up to 4 years

  2. Disease-free survival

    Estimated using the Kaplan-Meier methods.

    Time frame: Up to 4 years

  3. Event-free survival

    Estimated using the Kaplan-Meier methods.

    Time frame: Up to 4 years

  4. Duration of complete remission

    Complete remission rates will be estimated along with 95% credible intervals. Estimated using the Kaplan-Meier methods.

    Time frame: Up to 4 years

07

Study locations

4 sites
  • Augusta University
    Augusta, Georgia 30912, United States
  • Montefiore Medical Center, Albert Einstein College of Medicine
    The Bronx, New York 10467, United States
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
  • Huntsman Cancer Institute
    Salt Lake City, Utah 84112, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02530034
Lead sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Aug 20, 2015
Start date
Jan 31, 2019
Primary completion
Jan 1, 2027 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Sep 18, 2026

Study contacts

Tapan M Kadia
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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