Status:
NOT_YET_RECRUITING
Assessing Jet Administration of pBI-11 for the Treatment of Patients With HPV16/18+
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions:
HPV Infection
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This is a randomized phase II study. The primary goal of this study is to determine the safety and tolerability of three monthly pBI-11 DNA administrations in each thigh of patients with persistent hu...
Detailed Description
This is a randomized phase II study. The primary goal of this study is two-fold; one is to determine the safety and tolerability of three monthly pBI-11 DNA administrations in each thigh of patients w...
Eligibility Criteria
Inclusion
- 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).
- Age ≥ 18 years
- Baseline Eastern Cooperative Oncology Group performance status of 0, 1 at the time of treatment administration.
- 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
- 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.
- Ability to understand and the willingness to sign a written informed consent document.
- Subject is able to adhere to the study visit schedule and other protocol requirements.
Exclusion
- Histologic evidence of CIN2, cervical intraepithelial neoplasia 3 (CIN3), adenocarcinoma in situ or malignancy.
- Patients with a diagnosis of immunosuppression or active systemic use of immunosuppressive medications such as steroids.
- Patients who are receiving any other investigational agents within 28 days prior to the first dose.
- 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.
- 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.
- Patients who are pregnant or breast feeding or plan to become pregnant within five months of first study treatment.
- Patient with active infection of, or receiving treatment for Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), or Hepatitis B Virus (HBV).
- 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.
Key Trial Info
Start Date :
May 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06210854
Start Date
May 1 2026
End Date
October 1 2028
Last Update
October 23 2025
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