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New treatment option for Cervical Cancer
Official title E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers
ClinicalTrials.gov ID: NCT05686226
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 cervical cancer.
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
- This is a phase II clinical trial to assess the clinical activity of immunotherapy with E7 TCR-T cells for metastatic HPV-associated cancers. HPV-associated cancers in include cervical, throat, penile, vulvar, vaginal, anal, and other cancers.
- 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 or cytologically confirmed metastatic or refractory/recurrent HPV-16+ cancer.
- Tumor and/or blood with HPV16 genotype as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.
- HLA-A\ 02:01 allele as determined by testing performed in a CLIA certified laboratory. Participants may be enrolled based on low resolution typing...
- Measurable disease as assessed by RECIST Criteria Version 1.1.
You likely can't join if
- people who meet any of the following criteria will be excluded from participation in this study:
- Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or...
- History of severe allergic reactions to compounds of similar chemical or biological composition to agents used in this study.
- History of coronary revascularization or ischemic symptoms unless patient has a normal cardiac stress test.
- 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...
See the full eligibility criteria
Who can join
- people must meet all the following criteria to participate in this study.
- Histologically or cytologically confirmed metastatic or refractory/recurrent HPV-16+ cancer.
- Tumor and/or blood with HPV16 genotype as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.
- HLA-A\ 02:01 allele as 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...
- Measurable disease as assessed by RECIST Criteria Version 1.1.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at screening.
- Must have received prior first line standard therapy or have declined standard therapy.
- Standard treatment options for first and second-line therapy must be presented and formally declined (Appendix VII).
- Patients with three or fewer brain metastases that have been treated with surgery or stereotactic radiosurgery are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for...
- 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 antigen (HBsAg), and hepatitis C antibody. If a hepatitis C antibody test is positive, then testing for antigen by RT-PCR for hepatitis C (HCV) RNA must be negative.
- 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 transferase (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...
- More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the E7 TCR cells. Adverse events from prior therapy must have resolved to ≤ grade 1 according to CTCAE Version 5.0...
- 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) or NIH protocol 16C0061 (Rutgers 192202) for...
What rules you out
- people who meet any of the following criteria will be excluded from participation 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...
- History of severe allergic reactions to compounds of similar chemical or biological composition to agents used in this study.
- History of coronary revascularization or ischemic symptoms unless patient has a normal cardiac stress test.
- 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, then they may be reevaluated.
- people with HLA-A\ 02:01 damaging mutation or allele loss detected by clinical or research genomic profiling will not be eligible.
- 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 Participants with prior or concurrent malignancy that do not meet the above criteria are excluded.
- 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.
- Current treatment with another investigational agent.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
- 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 Bethesda, Maryland, United States; 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.