Hu8F4 for Blood Cancers

Phase 1

Waitlist Available

Led By Tapan M Kadia

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at the side effects and best dose of the drug Hu8F4 for treating patients with blood cancers. The drug may help stop cancer cells from growing and spreading.

Who is the study for?

This trial is for adults with advanced blood-related cancers like certain types of leukemia, myelodysplastic syndrome, or myelofibrosis. Participants must have specific genetic traits (HLA-A2), failed previous treatments, and be in good enough health to tolerate the study drug. Pregnant women are excluded and contraception is required during the trial.

What is being tested?

The trial tests Hu8F4, a monoclonal antibody that may block cancer growth. It's in phase I to determine safe dosage levels and side effects. Patients will undergo lab biomarker analysis and pharmacological studies to see how well Hu8F4 works against their cancer.

What are the potential side effects?

Potential side effects of Hu8F4 could include typical reactions seen with other monoclonal antibodies such as allergic reactions at the infusion site, fever, chills, nausea, fatigue, headache or more serious immune system related problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Biologically-effective dose

Minimum safety data

Secondary study objectives

Disease

Duration of complete remission

Event-free survival

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (Hu8F4)Experimental Treatment3 Interventions

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.

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