PDS0101 for HPV 16 Infection in People Living With HIV
This study is testing a treatment called PDS0101 in adults living with HIV who also have human papillomavirus (HPV) type 16. The goal is to see if PDS0101 is safe and if it can help your body's immune system fight HPV 16. Researchers plan to enroll 27 adults, aged 25 to 65, who are on stable HIV treatment and have HPV 16 detected in their cervix, vagina, or anus. Some participants may have a condition called HSIL (high-grade squamous intraepithelial lesions), which can lead to cancer. The study will measure safety by looking at serious side effects and how many participants receive all doses of PDS0101.
- Study design
- This is an interventional study enrolling 27 participants. The phase of the study is not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety and tolerability will be measured at 127 days after the start of the study.
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NCT07090174
CASCADE: Testing for Safety and Immune Effects of PDS0101, an Anti-HPV Therapy, Among People Living With HIV
Withdrawn
PHASE2Ages 25+InterventionalPreventionUniversity of California, San DiegoInvestigator-initiated
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:PDS0101
At a glance
Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety: Number of Grade 3 or greater adverse events (AE) at least possibly related to PDS0101.
Measured over 127 days
+1 more outcome measured
Conditions
Where it's being run
3 sites across 2 statesNew York2
Puerto Rico1
Study leadership
- Timothy Wilkin, MD, MPH · PRINCIPAL_INVESTIGATOR · University of California, San Diego
- Timothy Wilkin, MD, MPH · STUDY_CHAIR · University of California, San Diego
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
HPV 16 detected on anal swab, cervical swab or vaginal swab ≤90 days of registration. (Note: HPV 16 detected on this swab can be from the screening evaluation or through standard of care assessments. The HPV 16 assay must be FDA-cleared and report HPV 16 results separately. The assay must be performed in a CLIA-certified laboratory.)
Cervical HSIL cohort: CIN III/carcinoma in situ (CIS), CIN II/III, or CIN II with positive p16 stain diagnosed on cervical biopsy ≤90 days of registration and detection of cervical or vaginal HPV 16.
Cervical HSIL cohort: HSIL must occupy \<50% circumference of the cervical squamocolumnar junction, and adequate colposcopy with visualization of the endocervical HSIL margins. (Note: Participants with cervical HSIL occupying ≥50% of the circumference of cervical squamocolumnar junction and/or inadequate visualization of the endocervical HSIL margins are not eligible for this protocol.)
Anal HSIL cohort: anal intraepithelial neoplasia (AIN) III, AIN II/III, or AIN II with positive p16 stain diagnosed on anal or perianal biopsy ≤90 days of registration and detection of anal HPV 16.
Anal HSIL cohort: HSIL must occupy \<50% circumference of the squamocolumnar junction. (Note: Participants with anal HSIL occupying ≥50% of the circumference of cervical squamocolumnar junction are not eligible for this protocol.)
≥25 years of age.
HIV infection with receipt of antiretroviral therapy for at least 12 months.
CD4+ T-cell count ≥200 cells/mm3 ≤45 days of registration.
Plasma HIV-1 RNA \<200 copies/mL ≤45 days of registration.
Participants must meet the following laboratory parameters ≤45 days before enrollment:
Eastern Cooperative Oncology Group (ECOG) performance status ≤1 (or Karnofsky ≥70%).
Willingness to comply with three-dose immunotherapeutic agent schedule and subsequent study visits.
The effects of PDS0101 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception prior to study entry and for at least 120 days after the last dose of study treatment. Women of childbearing potential must have a negative urine pregnancy test (β-human chorionic gonadotropin) within 24 hours prior to registration and prior to visits on Days 1, 22, 43, 57, and 127. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately and will not receive any additional doses of immunotherapeutic agent. Women who become pregnant and partners of male participants who become pregnant will be followed to assess pregnancy outcomes.
Ability to understand and the willingness to sign a written informed consent form (ICF).
Exclusion
AIDS-defining condition within 6 months prior to study entry.
Receipt of blood products within 6 months of enrollment or are currently taking immune suppressants.
History of HPV-related cancer or suspected cancer of the cervix, anus, vagina, vulva, penis, or oropharynx.
Current diagnosis of cancer or prior invasive cancer \> T1 stage (other than non-melanoma skin cancer) that has required active treatment within the past 3 years.
Suspicion of invasive cancer of the cervix, vulva, vagina, perianus or anal canal. (Note: Concomitant vulvar, vaginal, or perianal HSIL is not exclusionary.)
Surgical or ablative treatment for anal or cervical HSIL within 180 days of study entry.
Prior receipt of any doses of a licensed or experimental HPV immunotherapeutic agent. (Note: Prior receipt of licensed prophylactic HPV vaccines is permitted.)
Planned use of intravaginal, vulvar, perianal or intra-anal imiquimod or 5-fluorouracil or another topical therapeutic agent with possible activity against HPV disease, or their use within ≤90 days of entry.
Receipt of a live vaccine within 30 days prior to the first dose of treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Coordination and timing of COVID-19 vaccination should be based on local Investigator clinical assessment and judgment.
Received immunotherapy/immunomodulatory or immunosuppressive agents (e.g., IFNs, tumor necrosis factor, interleukins, immunoglobulins or other biological response modifiers \[GM-CSF, granulocyte-macrophage colony-stimulating factor\]) within 6 weeks prior to administration of the first study treatment.
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 30 days prior to the first dose of study treatment. (Note: Participants who entered the follow-up phase of an investigational study may participate as long as it has been 30 days after the last dose of the previous investigational agent.)
Is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. Current or recent use of intra-articular, topical, or inhaled corticosteroids is acceptable.
Participants known to be positive for Hepatitis B antigen (HBsAg)/Hepatitis B virus (HBV) DNA or active Hepatitis C. Active Hepatitis C (HCV) is defined by a known positive HCV antibody result and known quantitative HCV RNA results greater than the lower limits of detection of the assay.
Plan to relocate during study period.
Acute medical conditions that would require exclusion from participation based on the opinion of the supervising physician.
Potential participants receiving any other investigational agents may be excluded in the opinion of the supervising physician.
Use of opioids within 2 weeks prior to enrollment. (Note: Medically assisted therapy for opioid use disorder or alcohol use disorder (e.g., stable methadone or buprenorphine/naloxone) are not exclusionary. The rationale for excluding other opioid use is to allow appropriate grading of injection-related pain.)
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. Current bacterial sexually transmitted infection (STI) requiring treatment (participants may participate after adequate treatment, at the discretion of the treating provider).
Pregnant or breastfeeding, unwilling/unable to use contraception, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of any study treatment.
Use of anticoagulants other than non-steroidal anti-inflammatory drugs or aspirin.
What this trial measures
- Safety: Number of Grade 3 or greater adverse events (AE) at least possibly related to PDS0101.127 days
Adverse events will be scored according to CTCAE v5.0 grading (Grade 1-Mild, Grade 2-Moderate, Grade 3-Severe, Grade 4-Life-threatening, and Grade 5-Fatal) except for injection site reactions (ISRs) grading, wherein they will be reviewed against 2007 FDA guidance. Skin discoloration is common with PDS0101, therefore skin discoloration (ISRs including erythema or pigment changes) \>10 cm and induration \>10 cm will not count as a primary safety endpoint. However, all of the detailed AEs will be reported as a supporting analysis including all ISRs. For the primary safety analysis, we will include all participants who receive at least one dose of PDS0101. Participants who only receive 1-2 doses who discontinue PDS0101/study participation for reasons other than a primary safety event will be replaced to assure 27 participants who receive all 3 doses or discontinue PDS0101 after 1-2 doses because of a primary safety event; those with primary safety event after 1-2 doses won't be replaced.
- Tolerability: Proportion of participants who receive all three doses.127 days
Participants who do not receive the first dose will be excluded from all analyses.