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New treatment option for HPV-Associated Cervical Carcinoma
Official title E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers
ClinicalTrials.gov ID: NCT05639972
What this study is testing
What is E7 TCR-T cells?
E7 TCR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hpv-associated cervical carcinoma.
Also referred to as E7 TCR, HPV TCR.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this study is to determine the feasibility of administration of a single dose of E7 TCR-T cells as induction therapy prior to definitive treatment (chemoradiation or surgery) of locoregionally advanced HPV-associated cancers. The intent of E7 TCR-T cell treatment is to shrink or eliminate tumors and thereby facilitate definitive therapy and increase overall survival.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people must meet all the following criteria to participate in this study.
- Histologically confirmed carcinoma of a primary tumor site and stage indicated in Table 3 of the protocol.
- Tumor with HPV16 genotype as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.
- HLA-A\ 02:01 allele determined by testing performed in a CLIA certified laboratory. Participants may be enrolled based on low resolution typing...
- Measurable disease per RECIST Criteria Version 1.1 or PERCIST.
You likely can't join if
- people who meet any of the following criteria will be excluded from participation in this study:
- Have received prior systemic therapy or definitive chemoradiation for the cancer that is being treated on this protocol. Palliative radiation therapy...
- Current treatment with another investigational agent.
- History of severe allergic reactions to compounds of similar chemical or biological composition to agents used in this study.
- Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or...
- people with HLA-A\ 02:01 damaging mutation or allele loss detected by research or clinical sequencing will not be eligible.
See the full eligibility criteria
Who can join
- people must meet all the following criteria to participate in this study.
- Histologically confirmed carcinoma of a primary tumor site and stage indicated in Table 3 of the protocol.
- Tumor with HPV16 genotype as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.
- HLA-A\ 02:01 allele determined by testing performed in a CLIA certified laboratory. Participants may be enrolled based on low resolution typing (i.e., HLA-A\ 02) but the HLA-A\ 02:01 allele type must be confirmed prior...
- Measurable disease per RECIST Criteria Version 1.1 or PERCIST.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.
- Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months. A pregnancy test is not required for women who have had a bilateral oophorectomy or hysterectomy.
- Men and women of child-bearing potential must agree to use adequate contraception (i.e., intrauterine device, hormonal barrier method of birth control, abstinence, tubal ligation, or vasectomy) prior to study entry and...
- Seronegative for HIV antibody, hepatitis B surface antigen (HBsAg), and hepatitis C antibody. If a hepatitis C antibody test is positive, then testing for antigen by reverse transcription polymerase chain reaction...
- Participants must have organ and marrow function as defined below:
- Leukocytes \> 3,000/mcL
- Absolute neutrophil count \> 1,500/mcL
- Platelets \> 100,000/mcL
- Hemoglobin \> 9.0 g/dL
- Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin \< 3.0 mg/dL.
- Serum aspartate aminotransferase (AST) (SGOT)/ alanine transaminase (ALT) (SGPT) \< 2.5 x upper limit of normal (ULN)
- Calculated creatinine clearance (CrCl) \>50 mL/min/1.73 m2 for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation).
- International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy. people on anticoagulant therapy must have a PT or aPTT within...
- Participants must be able to understand and be willing to sign the written informed consent document.
- Participants must agree to participate in Rutgers protocol 192103 (Pro2021002307) for gene therapy long term follow up and in Rutgers protocol 192002 (Pro2021000281) for biospecimen studies. Note: Patients may have...
What rules you out
- people who meet any of the following criteria will be excluded from participation in this study:
- Have received prior systemic therapy or definitive chemoradiation for the cancer that is being treated on this protocol. Palliative radiation therapy for symptom management, such as to control tumor-induced bleeding, is...
- Current treatment with another investigational agent.
- History of severe allergic reactions to compounds of similar chemical or biological composition to agents used in this study.
- Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations at the time of treatment that...
- people with HLA-A\ 02:01 damaging mutation or allele loss detected by research or clinical sequencing will not be eligible.
- Documented LVEF of less than or equal to 45% tested. The following participants will undergo cardiac evaluations:
- Clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or
- Age ≥ 50 years old
- Participants with baseline screening pulse oxygen level of ≤ 92% on room air will not be eligible. If the underlying cause of hypoxia improves, they may be reevaluated.
- Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7 TCR T cells, breastfeeding should be discontinued if the mother is treated with E7 TCR T...
- Participants with a systemic immunodeficiency including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease are ineligible. The experimental treatment being...
- Participants on immunosuppressive drugs including corticosteroids unless meeting criteria outlined in Section 6.1 (Prohibited Medications).
- Participants with potentially severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus are not...
- Participants with prior or concurrent malignancy whose natural history or treatment is unlikely to interfere with the safety or how well it works assessments of the investigational regimen are eligible for this trial...
- Carcinoma in situ
- Cutaneous skin cancers requiring only local excision
- Low grade non-muscle invasive bladder cancer
- Low grade prostate cancer
- people who received a live vaccine within 30 days prior to enrollment are not eligible.
- Determination by the Principal Investigator that participation is not in the best interest of the research subject or may jeopardize the safety of the subject or integrity of the clinical trial data.
The study team makes the final eligibility decision.
Where it's taking place
- New Brunswick, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Brunswick, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.