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CAR T-cell Therapy
E7 TCR-T Cells for HPV-Related Cervical and Throat Cancer
Phase 2
Recruiting
Led By Christian 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 five years
Awards & highlights
Study Summary
This trial will test an immunotherapy treatment for HPV-associated cancers, such as cervical and throat cancer. Participants receive a conditioning regimen, cells, and drug to assess response.
Who is the study for?
This trial is for adults with metastatic or recurrent HPV-16+ cancers, including cervical, throat, penile, vulvar, vaginal, and anal cancers. They must have the HLA-A*02:01 allele and measurable disease by RECIST criteria. Participants need proper organ function and an ECOG status of 0 or 1. They should have tried standard therapy or declined it and agree to use contraception.Check my eligibility
What is being tested?
The trial tests E7 TCR-T cell immunotherapy in patients with HPV-associated cancers that are metastatic or resistant to treatment. It includes a conditioning regimen followed by E7 TCR-T cells infusion and aldesleukin administration to evaluate the clinical response.See study design
What are the potential side effects?
Potential side effects may include immune system reactions leading to inflammation in various organs (immune-related adverse events), symptoms related to cytokine release such as fever and fatigue (cytokine release syndrome), infusion reactions during cell transfusion, as well as general discomforts like nausea.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Tumor response
Secondary outcome measures
Adverse Events
Trial Design
1Treatment groups
Experimental Treatment
Group I: E7 TCR-T cellsExperimental Treatment1 Intervention
Subjects will receive a conditioning regimen, E7 TCR-T cells, and aldesleukin.
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Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
64,212 Total Patients Enrolled
3 Trials studying Adenocarcinoma
295 Patients Enrolled for Adenocarcinoma
Christian HinrichsLead Sponsor
2 Previous Clinical Trials
57 Total Patients Enrolled
1 Trials studying Adenocarcinoma
15 Patients Enrolled for Adenocarcinoma
Christian Hinrichs, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have HIV, hepatitis B, or active hepatitis C.My cancer is confirmed to be HPV-16+ and has spread or not responded to treatment.My tumor is HPV16 positive, confirmed by a certified lab test.I've had 3 or fewer brain tumors treated and am stable for 1 month.I have either undergone or declined the first round of standard treatment.I am a woman under 55 or have had a period in the last year and not pregnant.I agree to use effective birth control during and for four months after the study.My genetic test shows I have the HLA-A*02:01 allele.I have declined standard first and second-line cancer treatments.I am 18 years old or older.I am fully active or restricted in physically strenuous activity but can do light work.
Research Study Groups:
This trial has the following groups:- Group 1: E7 TCR-T cells
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Adenocarcinoma Patient Testimony for trial: Trial Name: NCT05686226 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned E7 TCR-T cells for medicinal use?
"The well-being of patients receiving E7 TCR-T cells has been assessed as a 2, since this is Phase 2 and there are some safety data but no efficacy evidence yet."
Answered by AI
Are there any available opportunities to join this research endeavor?
"The latest clinicaltrials.gov data indicates that no more participants are being recruited for this particular trial, which was initially posted on March 30th 2023 and last updated on January 8th 2021. Fortunately, 3765 other medical studies are currently enrolling patients."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
RWJBarnabas Health - Robert Wood Johnson University Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Ok so I have had HPV since I was a lot younger and about two years ago I was told that I had abnormal cells and needed more invasive check out done , I never went back!! My mother died from cervical cancer and I don't know what those big words are but I have records stateing I have HPV , I really want this opportunity to get help with this and if not at least be able to help you save someone else life . I'm willing to travel, I'm down like 4 flats and a Cadillac!! Thank you for your time and interest.
PatientReceived no prior treatments
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