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E7 TCR-T Cells for HPV-Related Cancer

Phase 1 & 2

Waitlist Available

Led By Christian S Hinrichs, MD

Research Sponsored by Rutgers, The State University of New Jersey

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 5 years

Awards & highlights

Study Summary

This trial aims to find out if E7 TCR-T cell treatment can shrink or eliminate HPV-associated cancers to facilitate definitive therapy & increase survival.

Who is the study for?

Adults over 18 with advanced HPV-related cancers (like cervical, anal, and oropharyngeal cancer) that have the HPV16 genotype. They must be in good health with proper organ function and not HIV or hepatitis positive. Women of childbearing age should use contraception and cannot be pregnant.Check my eligibility

What is being tested?

The trial is testing E7 TCR-T cells as a pre-treatment to shrink tumors before main treatment like surgery or chemoradiation. It involves taking patients' T cells, modifying them to fight cancer, then giving them back along with aldesleukin to boost the immune system.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune response such as fever, fatigue, inflammation around various organs; complications from cell infusion; and effects from aldesleukin like chills and nausea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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

Feasibility of administering E7 TCR-T cell therapy as induction treatment for LAHPVC

Secondary outcome measures

2-year and 5-year disease free survival (DFS)

Objective tumor response rate at 6-weeks after treatment

Side effects data

From 2019 Phase 2 trial • 10 Patients • NCT03007238

30%

Anemia

20%

Sepsis

20%

Hypertension

20%

Hypophosphatemia

20%

Hyperglycemia

20%

Dyspnea

10%

Bronchial infection

10%

Pneumonitis

10%

Hypotension

10%

Catheter related infection

10%

Hypokalemia

10%

Headache

10%

Anal pain

10%

Anorexia

10%

Oral pain

10%

CD4 lymphocytes decreased

10%

Alanine aminotransferase increased

10%

Lymphocyte count decreased

10%

Nausea

10%

Non-cardiac chest pain

10%

Hypercalcemia

10%

Vascular access complication

10%

Adult respiratory distress syndrome

10%

Atrial flutter

10%

Platelet count decreased

10%

Hyponatremia

100%

80%

60%

40%

20%

Study treatment Arm

Overall Study

Trial Design

1Treatment groups

Experimental Treatment

Group I: Conditioning, E7 TCR-T cells, and aldesleukinExperimental Treatment1 Intervention

Participants will receive a conditioning regimen consisting of cyclophosphamide and fludarabine followed by E7 TCR-T cells cells IV x 1 dose, followed by aldesleukin every 8 hours for up to 3 doses.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

64,217 Total Patients Enrolled

19 Trials studying Carcinoma

636 Patients Enrolled for Carcinoma

Christian HinrichsLead Sponsor

2 Previous Clinical Trials

62 Total Patients Enrolled

1 Trials studying Carcinoma

20 Patients Enrolled for Carcinoma

National Cancer Institute (NCI)NIH

13,687 Previous Clinical Trials

40,930,356 Total Patients Enrolled

1,395 Trials studying Carcinoma

387,309 Patients Enrolled for Carcinoma

Frequently Asked Questions

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

Are there any vacancies remaining in this research project?

"According to the information found on clinicaltrials.gov, this research trial is not actively recruiting participants. Originally posted on January 1st 2023 and last updated November 28th 2022, while no longer seeking patients it should be noted that there are 3707 other ongoing trials searching for volunteers at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers

Christian Hinrichs 2024. "E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05639972.

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