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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 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 five years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new treatment using modified immune cells to fight cancers caused by HPV. It targets patients with specific types of cancer linked to HPV who have a certain genetic marker. The treatment works by reprogramming the patient's immune cells to attack the cancer cells.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Tumor response
Secondary study objectives
Adverse Events
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: E7 TCR-T cellsExperimental Treatment2 Interventions
Subjects will receive a conditioning regimen, E7 TCR-T cells, and aldesleukin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aldesleukin
2012
Completed Phase 4
~1610
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Adenocarcinoma, particularly those similar to E7 TCR-T cells, include immunotherapies such as checkpoint inhibitors and genetically engineered T cells. Checkpoint inhibitors, like pembrolizumab, work by blocking proteins that prevent the immune system from attacking cancer cells, thereby enhancing the body's immune response against the tumor.
Genetically engineered T cells, such as CAR-T cells, are modified to specifically target cancer cell antigens, leading to direct tumor cell destruction. These treatments are significant for Adenocarcinoma patients as they offer targeted approaches that can potentially improve outcomes by harnessing the body's own immune system to fight cancer more effectively.
Find a Location
Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
450 Previous Clinical Trials
65,804 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,018,009 Total Patients Enrolled
Christian HinrichsLead Sponsor
2 Previous Clinical Trials
45 Total Patients Enrolled
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.
Anal Cancer Patient Testimony for trial: Trial Name: NCT05686226 — Phase 2
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