Phase 1 Cervical Cancer Trial, Recruiting NCT05829629 Sponsor: BlueSky Immunotherapies GmbH Condition: Cervical Cancer
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Phase 1 Cervical Cancer Trial, Recruiting

NCT05829629
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Women aged 18 to 49 who have been infected with a specific strain of HPV called HPV16, and whose cervical cell test results show either normal cells or only mild/low-grade changes
  • People whose HPV16 infection has been confirmed by two separate validated tests, taken at least 3 months apart
  • People who have had a satisfactory colposcopy (a close-up examination of the cervix)
  • People whose blood tests show no significant problems with blood counts, kidney function, or liver function
  • People whose heart trace (ECG) reading is normal or has no significant concerns, as judged by the doctor running the trial
  • People who have a negative pregnancy blood test at the screening visit
  • People who agree to use a reliable form of contraception for the entire duration of the study
  • People who have provided written consent to participate in the trial

Who may not be able to join:

  • People who have received any vaccine within 6 weeks before the first study day
  • People who have had an active significant viral infection (such as influenza, CMV, or EBV) within 30 days before receiving the study treatment
  • People who also have hepatitis B, hepatitis C, or HIV, or who have any other condition that weakens the immune system
  • People who currently have a bacterial vaginal infection known as bacterial vaginosis
  • People who currently have higher-grade cervical cell changes (known medically as CIN2 or CIN3)
  • People who have a current or past history of certain more serious cervical or gynaecological cell changes, or any suspicion of early or invasive cancer
  • People who are currently pregnant or breastfeeding
  • People who have had a flu-like illness within 3 months before the first study day
  • People who have a known allergy or sensitivity to the drug oseltamivir (Tamiflu) or any of its ingredients
  • People who have a physical condition of the cervix — such as from previous cervical surgery, a birth difference, or another condition — that would prevent a complete cervical examination
  • People who currently have pelvic inflammatory disease, cervical inflammation, or another gynaecological infection detected during examination
  • People who have a serious ongoing medical condition, including an active infection that requires treatment
  • People who have an active or long-term bleeding or clotting disorder, or who have taken blood-thinning medication within 2 weeks before the first study day
  • People who have a confirmed or suspected autoimmune disease
  • People whose immune system is suppressed, including those taking ongoing steroid medications or immunosuppressive drugs (certain treatments for airway, ear, or balance conditions may be an exception — confirm with trial site)
  • People who have a current or past history of genital herpes
  • People who have had major surgery within 4 weeks before the first study day
  • People who have received any blood products within 3 months before joining the trial
  • People who have a significant current or past history of heart, liver, or kidney disease that has been medically unstable
  • People who have a current or past neurological condition, including a history of seizures
  • People who have taken part in another clinical trial or received an experimental drug within the two months before this trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 6 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +43 664 1888028

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
BlueSky Immunotherapies GmbH
Registry
ClinicalTrials.gov
Start date
12 September 2023
Est. completion
1 September 2025

Where this trial is recruiting

🇸🇰 Slovakia

Primary endpoints

Frequency and severity of adverse events (AEs)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 6 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov