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CAR T-cell Therapy

HPV Specific T Cells + Immunotherapy for Cancer (HESTIA Trial)

Phase 1
Waitlist Available
Led By Carlos Ramos, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
PROCUREMENT
Age ≥ 18 years.
Must not have
Severe intercurrent infection.
Known HIV positivity.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is for people with HPV-associated cancers that have come back or have not gone away after standard treatment, or for whom standard treatment is not an option. The trial will test a new experimental treatment consisting of special immune system cells called HPVST cells.

Who is the study for?
This trial is for adults over 18 with recurrent or persistent HPV-associated cancers after standard treatment, or those who can't receive standard therapy. Participants need a Karnofsky score of at least 50%, indicating they are able to perform daily activities. They must have a life expectancy of more than 6 weeks, adequate organ function, and agree to use effective birth control. People with HIV, current investigational treatments, severe infections, or who are pregnant cannot join.
What is being tested?
The study tests HPV-specific T cells (HPVST) designed to fight cancer by targeting the virus that causes it. The first group receives only these cells; if safe, another group will get them plus Nivolumab—an FDA-approved antibody—in a lymphodepleted state to potentially enhance effectiveness.
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as fatigue, fever and chills during infusion of T cells. Nivolumab may cause skin rash, digestive issues like diarrhea or liver inflammation which could lead to jaundice.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My cancer has come back or didn't respond to treatment, or I can't have standard treatment.
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My kidney function is good, with a GFR over 30 mL/min.
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I am able to care for myself but cannot do normal activities or work.
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My cancer is linked to high-risk HPV.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have a severe ongoing infection.
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I am HIV positive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of patients with dose limiting toxicity (DLT)
Secondary study objectives
Overall response rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group BExperimental Treatment4 Interventions
HPV Specific T Cells plus lymphodepletion (Cytoxan and Fludarabine) and nivolumab
Group II: Group AExperimental Treatment1 Intervention
HPV Specific T Cells
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~5220
Cytoxan
2007
Completed Phase 3
~1460
Fludarabine
2012
Completed Phase 4
~1860

Find a Location

Who is running the clinical trial?

Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
112 Previous Clinical Trials
2,805 Total Patients Enrolled
The Methodist Hospital Research InstituteOTHER
284 Previous Clinical Trials
81,604 Total Patients Enrolled
Baylor College of MedicineLead Sponsor
1,022 Previous Clinical Trials
6,029,388 Total Patients Enrolled

Media Library

HPV Specific T Cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02379520 — Phase 1
Penile Cancer Research Study Groups: Group A, Group B
Penile Cancer Clinical Trial 2023: HPV Specific T Cells Highlights & Side Effects. Trial Name: NCT02379520 — Phase 1
HPV Specific T Cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02379520 — Phase 1
~3 spots leftby Nov 2025
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