HARE-40: HPV Anti-CD40 RNA vaccinE

Korábbi kezelés

• Any patient who has been previously vaccinated with BNT113 in any Arm of the trial.
• Major surgery in the preceding three to four weeks, which the patient has not yet recovered from.
• Patients with any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial, such as concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease.
• Patients who are serologically positive for or are known to suffer from Hepatitis B, C, Syphilis or HIV. Counselling will be offered to all patients prior to testing.
• Any other investigational drug within 28 days or 5 half-lives depending on what gives the longer range before the first treatment of this study

Más betegség

• Systemic steroids (prednisolone \>10 mg/day or equivalent) or other drugs with a likely effect on immune competence are forbidden during the trial. The predictable need of their use will preclude the patient from trial entry. Replacement steroids for adrenal insufficiency/failure are allowed.
• Patients who are of high medical risk because of non-malignant systemic disease, as well as those with active uncontrolled infection.
• Patients with clinically relevant autoimmune disease will be excluded.
• Patients who are known to be allergic to any of the excipients or constituents of the vaccine
• Current malignancies at other sites, with the exception of adequately treated basal or squamous cell carcinoma of the skin. For Arm 1A; cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for five years and are deemed at low risk for recurrence, are eligible for the trial. For Arm 1B; cancer survivors, who have undergone potentially curative therapy for a prior malignancy, and have no evidence of that disease for one year, are eligible for the trial.

Laborértékek

• Elevated Liver Function Tests - ALT \>3.0 x ULN, AST \>3.0 x ULN, Bilirubin \>3.0 x ULN.
• Arm 1B patients with the presence of liver metastasis only: Elevated Liver Function Tests - ALT \>5.0 x ULN, AST \>5.0 x ULN, ALP \>5.0 x ULN. Patients who are likely to have rapid disease progression may not be good candidates for the trial. In such cases, please discuss with the Chief Investigator.

Életkor

• \<18 years

Egyéb

• Patients unable to consent.
• Patients who have a positive pregnancy test or who are breast feeding.
• Fertile males or females who are unable or unwilling to use an effective method of birth control (eg. condom with spermicide, diaphragm with spermicide, birth control pills, injections, patches, intrauterine device, or intrauterine hormone-releasing system) during study treatment and until 28 days after patients finish the study treatment.

• Arm 1A:
• Previous HPV16+ head and neck squamous cell carcinoma.
• At least 12 months after completion of treatment.
• Within 5 years of treatment completion.
• Currently no clinical evidence of disease.
• ECOG performance status 0 or 1.
• Patient has adequate venous access in order to obtain all required blood samples and to undergo Leukapheresis as per protocol
  • Arm 1B:
• HPV16+ head and neck, cervical, anogenital and penile carcinoma patients with recurrent disease.
• Intention to treat is palliative.
• Tissue samples available confirming HPV16+ disease to send to Central Laboratory.
• Patient has adequate venous access in order to obtain all required blood samples and to undergo Leukapheresis as per protocol