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
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.
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.
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 →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.
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Exclusion Criteria:
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
Given IV
Also known as: Hu8F4
Correlative studies
Correlative studies
Minimum safety data
Safety data will be summarized using frequency and percentage for all patients.
Time frame: 4 weeks
Biologically-effective dose
Safety data will be summarized using frequency and percentage for all patients.
Time frame: 4 weeks
Overall survival
Estimated using the Kaplan-Meier methods.
Time frame: Up to 4 years
Disease-free survival
Estimated using the Kaplan-Meier methods.
Time frame: Up to 4 years
Event-free survival
Estimated using the Kaplan-Meier methods.
Time frame: Up to 4 years
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
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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M.D. Anderson Cancer Center