Assessing Jet Administration of pBI-11 for the Treatment of Patients With HPV16/18+

Launched by SIDNEY KIMMEL COMPREHENSIVE CANCER CENTER AT JOHNS HOPKINS · Jan 8, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Assessing Jet Administration of pBI-11 for the Treatment of Patients With HPV16/18+", is looking at a new treatment for women who have a persistent infection with human papillomavirus (HPV) types 16 or 18. The main goal is to see how safe and well-tolerated the treatment is when given three times a month in the thigh. This study is currently not recruiting participants, and only women aged 18 and older will be eligible. To join, participants must have a specific type of HPV but no severe cervical changes or cancer, and they should be in good health overall.

If you or someone you know is considering participating in this trial, you'll receive the treatment through a special jet delivery method. Participants will need to commit to regular visits for the study and agree to use effective birth control if they can get pregnant. It’s important to note that there are certain health conditions that may exclude someone from joining, such as having a weakened immune system or a history of certain serious illnesses. Overall, this trial aims to explore a potential new approach to treating HPV infections, which could benefit many women in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• 1. Patients must have:
• • Negative for Intraepithelial Lesions (NEIL), Atypical Squamous Cells of Undetermined Significance (ASC-US), or Low-grade Squamous Intraepithelial Lesion (LSIL) determined by cervical cytology
• • AND
• • HPV16 and/or 18+ by Roche Cobas 4800, Roche Linear Array HPV Genotyping test, or other FDA-approved HPV genotyping test (Co-infections with HPV types other than HPV16/18 are permissible).
• • 2. Age ≥ 18 years
• • 3. Baseline Eastern Cooperative Oncology Group performance status of 0, 1 at the time of treatment administration.
• 4. Patients must have adequate organ function at the time of enrollment as defined by the following parameters:
• • White blood cell count ≥ 3,000
• • Absolute lymphocyte number ≥ 500
• • Absolute neutrophil count ≥ 1,500
• • Platelets ≥ 90,000
• • Hemoglobulin ≥ 9
• • Total bilirubin \< 3 X the institutional limit of normal
• • Aspartate Aminotransferase (AST)/Alanine Aminotransferase(ALT) \< 3 X the institutional limit of normal
• • Creatinine \< 2.5 X the institutional limit of normal
• • 5. Women of child-bearing potential must agree to use long acting contraception (e.g. tubal ligation, intrauterine devine or hormonal implant) or two forms of contraception (e.g. barrier method, oral contraceptives) prior to study entry and for 3 months after final vaccination.
• • 6. Ability to understand and the willingness to sign a written informed consent document.
• • 7. Subject is able to adhere to the study visit schedule and other protocol requirements.
• Exclusion Criteria:
• • 1. Histologic evidence of CIN2, cervical intraepithelial neoplasia 3 (CIN3), adenocarcinoma in situ or malignancy.
• • 2. Patients with a diagnosis of immunosuppression or active systemic use of immunosuppressive medications such as steroids.
• • 3. Patients who are receiving any other investigational agents within 28 days prior to the first dose.
• • 4. Patients with an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• • 5. Patients with a history of systemic autoimmune disease such as multiple sclerosis or systemic lupus erythematosus (SLE), but exclusive of a history of thyroiditis, psoriasis, Sjrogen's, or inflammatory bowel disease.
• • 6. Patients who are pregnant or breast feeding or plan to become pregnant within five months of first study treatment.
• • 7. Patient with active infection of, or receiving treatment for Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), or Hepatitis B Virus (HBV).
• • 8. History of prior malignancy with disease free interval \<5 years; however, individuals with completely resected basal cell or squamous cell carcinoma of the skin within this interval may be enrolled.