What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for adenocarcinoma include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy can cause side effects such as nausea, vomiting, hair loss, fatigue, and increased risk of infection. Targeted therapies, which focus on specific molecular targets, may lead to side effects like skin rash, diarrhea, and liver toxicity. Immunotherapy, including treatments similar to E7 TCR-T cells, can result in immune-related adverse events such as skin reactions, endocrine disorders, pneumonitis, and colitis. These therapies aim to harness the body's immune system to fight cancer but can also cause inflammation and autoimmune-like symptoms.

What prior FDA approvals exist?

FDA-approved treatments for adenocarcinoma have included various immunotherapy drugs, such as checkpoint inhibitors like pembrolizumab and nivolumab. These drugs target proteins like PD-1 to enhance the immune system's ability to fight cancer. While specific genetically engineered T cell therapies targeting HPV E7 protein, like the E7 TCR-T cells, are still under investigation, other T cell therapies such as CAR-T cells have been approved for different types of cancers, including certain leukemias and lymphomas.

What other types of research exist?

Promising alternatives to E7 TCR-T cells for adenocarcinoma patients include: 1) Pembrolizumab, an immune checkpoint inhibitor targeting PD-1, which is used in various cancers with high TMB or dMMR. 2) CAR-T cell therapies, such as P-PSMA-101 for prostate cancer, which may be adapted for other adenocarcinomas. 3) Combination therapies like durvalumab plus tremelimumab, especially for tumors with high TMB. These options are based on their efficacy in clinical trials and potential applicability to adenocarcinomas.

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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

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

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

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

~1620

Do I qualify?Apply below to find out

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

440 Previous Clinical Trials

65,362 Total Patients Enrolled

3 Trials studying Adenocarcinoma

295 Patients Enrolled for Adenocarcinoma

National Cancer Institute (NCI)NIH

13,842 Previous Clinical Trials

41,002,980 Total Patients Enrolled

440 Trials studying Adenocarcinoma

80,603 Patients Enrolled for Adenocarcinoma

Christian HinrichsLead Sponsor

2 Previous Clinical Trials

45 Total Patients Enrolled

1 Trials studying Adenocarcinoma

15 Patients Enrolled for Adenocarcinoma

Media Library

E7 TCR-T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05686226 — Phase 2

Adenocarcinoma Research Study Groups: E7 TCR-T cells

Adenocarcinoma 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

Adenocarcinoma Patient Testimony for trial: Trial Name: NCT05686226 — Phase 2

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