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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

HESTIA Trial 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.Check my eligibility

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.See study design

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.

HESTIA Trial 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.

HESTIA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of patients with dose limiting toxicity (DLT)

Secondary outcome measures

Overall response rate

HESTIA 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

~4750

Cytoxan

2007

Completed Phase 3

~1460

Fludarabine

2012

Completed Phase 3

~1100

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Center for Cell and Gene Therapy, Baylor College of MedicineOTHER

111 Previous Clinical Trials

2,785 Total Patients Enrolled

The Methodist Hospital Research InstituteOTHER

271 Previous Clinical Trials

80,343 Total Patients Enrolled

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,148 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

Frequently Asked Questions

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

Are there any other research projects that have explored HPV Specific T Cells?

"Currently, 1582 studies concerning HPV Specific T Cells are running with 241 of them in the final phase. Most trials for HPV Specific T Cells take place in Philadelphia, Pennsylvania; however, 67813 sites worldwide are conducting research on this topic."

Answered by AI

How hazardous is the application of HPV Specific T Cells to patients?

"Our team has assigned HPV Specific T Cells a score of 1, as this is an early Phase 1 clinical trial and thus the safety profile is not yet fully elucidated."

Answered by AI

Are researchers actively seeking participants for this investigation?

"According to the clinicaltrials.gov database, this specific study is not recruiting participants at this time. Initially posted on September 1st 2015 and last updated on January 10th 2022, there are 4110 other trials currently open for enrollment."

Answered by AI

What is the maximum capacity for participants in this experiment?

"This medical trial has already been concluded, as the last update was on January 10th 2022. If you're seeking other clinical studies, there are currently 2528 trials actively enrolling patients with vulvar cancer and 1582 HPV-specific T cell related trials available for participation."

Answered by AI

In which conditions does HPV Specific T Cell therapy typically provide relief?

"HPV Specific T Cells are frequently used in the treatment of multiple sclerosis, and have also been known to provide relief for those with leukemia, myelocytic neoplasms, acute malignant disorders, and advanced melanoma."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

HPV-16/18 E6/E7-Specific T Lymphocytes, Relapsed HPV-Associated Cancers, HESTIA

Carlos Ramos 2015. "HPV-16/18 E6/E7-Specific T Lymphocytes, Relapsed HPV-Associated Cancers, HESTIA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02379520.

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