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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 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

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
454 Previous Clinical Trials
69,857 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,112,063 Total Patients Enrolled
Christian HinrichsLead Sponsor
2 Previous Clinical Trials
45 Total Patients Enrolled
Christian S Hinrichs, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey
2 Previous Clinical Trials
45 Total Patients Enrolled
Christian Hinrichs, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey

Media Library

E7 TCR-T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05686226 — Phase 2
Anal Cancer Research Study Groups: E7 TCR-T cells
Anal Cancer Clinical Trial 2023: E7 TCR-T cells Highlights & Side Effects. Trial Name: NCT05686226 — Phase 2
E7 TCR-T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05686226 — Phase 2
Anal Cancer Patient Testimony for trial: Trial Name: NCT05686226 — Phase 2
~0 spots leftby Jan 2025