Is NCT05686226 recruiting in New Brunswick, NJ?

Yes, NCT05686226 is currently recruiting participants at its New Brunswick, NJ location. This hpv cancer clinical trial is actively enrolling qualified participants.

How do I join the hpv cancer clinical trial in New Brunswick?

To join this clinical trial in New Brunswick, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this New Brunswick clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

HPV Cancer Clinical Trial in New Brunswick, NJ

About This HPV Cancer Study in New Brunswick

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. Participants will receive a conditioning regimen, E7 TCR-T cells, and aldesleukin. Clinical response to treatment will be determined.

Sponsor: Christian Hinrichs

Who Can Participate

Inclusion Criteria

Subjects 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 prior to apheresis.

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 one month before protocol treatment. Patients must be fully recovered from surgery.

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 for four months after treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.

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. Subjects on anticoagulant therapy must have a PT or aPTT within therapeutic range and no history of severe hemorrhage.

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 or have demonstrated clinical stability for the protocol.

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 biospecimen collection study. Note: Participants may have undergone minor surgical procedures with the past three weeks, as long as all toxicities have recovered to Grade 1 or less.

Exclusion Criteria

Subjects 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 would limit compliance with study requirements.

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.

Subjects 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 cells. These potential risks may also apply to other agents used in this study.

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 evaluated in this protocol depends on an intact immune system. Participants who have decreased immune competence may be less responsive to the treatment.

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 eligible. Patients with less severe autoimmune diseases such as hypothyroidism, vitiligo, and other minor autoimmune disorders are eligible.

Participants with prior or concurrent malignancy whose natural history or treatment is unlikely to interfere with the safety or efficacy assessments of the investigational regimen are eligible for this trial. Examples include, but are not limited to:

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.

Subjects 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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New Brunswick?

Yes, this clinical trial (NCT05686226) has an active research site in New Brunswick, NJ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

HPV Cancer Treatment Options in New Brunswick, NJ

If you're searching for hpv cancer treatment options in New Brunswick, NJ, this clinical trial (NCT05686226) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New Brunswick research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced hpv cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hpv cancer clinical trials near you to find additional studies recruiting in your area.

HPV Cancer Clinical Trial in New Brunswick, NJ

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