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Monoclonal Antibodies

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
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 the time of enrollment or have declined hematopoietic stem cell transplantation
Clinically significant toxicities from prior chemotherapy must not be greater than grade 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a disease that has come back or is not responding to treatment, and you have tried and failed all other available treatments. You are also not eligible or have chosen not to have a specific type of stem cell transplant.
Select...
You should not have experienced severe side effects (grade 2 or higher) from previous chemotherapy.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Biologically-effective dose
Minimum safety data
Secondary outcome measures
Disease
Duration of complete remission
Event-free survival
+1 more

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.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,377 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,574 Total Patients Enrolled
1 Trials studying Blood Cancers
70 Patients Enrolled for Blood Cancers
Tapan M KadiaPrincipal InvestigatorM.D. Anderson Cancer Center
13 Previous Clinical Trials
1,101 Total Patients Enrolled

Media Library

Blood Cancers Research Study Groups: Treatment (Hu8F4)
Hu8F4 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02530034 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What do researchers wish to determine through this experiment?

"This 4 week trial will primarily evaluate the safety of a given medication. The secondary objectives include Event-free Survival, Duration of Complete Remission and Overall Survival which can be estimated using Kaplan-Meier methods."

Answered by AI

Is the research initiative currently recruiting participants?

"According to the clinicaltrials.gov registry, this medical trial is selecting participants at present. Initially posted on January 31st 2019, it was last modified by researchers on September 22nd 2022."

Answered by AI

How many research participants have been recruited for this investigation?

"This clinical trial requires 72 volunteers that meet the predetermined criteria. Potential participants can find locations in Huntsman Cancer Institute, Salt Lake City and Augusta University, Georgia."

Answered by AI

Has the FDA sanctioned Anti-PR1/HLA-A2 Monoclonal Antibody Hu8F4?

"Our team has assessed the safety of Anti-PR1/HLA-A2 Monoclonal Antibody Hu8F4 with a score of 1 due to the limited data available from it's current Phase 1 trial."

Answered by AI
~12 spots leftby Mar 2025