UnknownPhase 1

HPV-T in HPV-16 Positive Recurrent or Metastatic Solid Tumors

China12 participantsStarted 2023-04-13

Plain-language summary

The purpose of this protocol is to evaluate the feasibility and safety of HPV-T in HPV 16 positive recurrent or metastatic solid tumor patients.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Greater than or equal to 18 years of age and less than or equal to 75 years of age; all genders.
✓. Confirmed diagnosis of recurrent of metastatic solid tumor and at least one measurable lesion.
✓. HLA type is HLA-A0201.
✓. HPV 16 positive.
✓. Patients who failed or were intolerant to standard first-line treatment.
✓. Possess venous access for mononuclear cell collection or intravenous blood collection.
✓. Clinical performance status of ECOG is 0 or 1.
✓. Possess venous access for mononuclear cell collection or intravenous blood collection.

Exclusion criteria

✕. Pregnant or lactating women.
✕. History of severe immediate hypersensitivity reaction to HPV-T and any of the agents used in this study.
✕. Participants with a history of organ transplantation.
✕. Participants with brain metastases.
✕. Any active autoimmune disease or participants with a history of autoimmune diseases that have been assessed by the investigator to be unsuitable for this study. Including but not limited to the following diseases: such as systemic lupus erythematosus, immune related neuropathy, multiple sclerosis, Guillain Barre syndrome, myasthenia gravis, connective tissue diseases, inflammatory bowel diseases(Crohn's disease and ulcerative colitis), excluding vitiligo, eczema, type I diabetes, rheumatoid arthritis and other joint diseases, Sjogren's syndrome and controlled psoriasis by local medication.
✕. Active systemic infections, for example, acute infections requiring systemic antibiotic, antiviral, or antifungal treatment occur within 2 weeks before enrollment.
✕. Severe liver and kidney function damage(given treatment is still uncontrollable, and biochemical indicators cannot meet the Exclusion Criteria of 11th), uncontrollable diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease, or poorly controlled hypertension (systolic pressure\>160mmHg and/or diastolic pressure\>90mmHg); active cardiovascular and cerebrovascular diseases, such as acute stroke, myocardial infarction, unstable angina, congestive heart failure rated as Grade II or above by the New York Heart Association, severe cardiac arrhythmias that cannot be controlled with medication, electrocardiograms show significant abnormalities (three consecutive times with an interval of at least 5 minutes) which have been assessed by the investigator that affect subsequent cellular treatment; mental illness and drug abuse, or any situation that the investigator assessments may increase the risk of this study.
✕. Participants plan to receive glucocorticoid (the dose of prednisone or alternative drug is more than 10mg per day) or other immunosuppressant within 4 weeks before the administration of lymphocyte clearance. Tips: when there is no active autoimmune disease, it is allowed to use prednisone or alternative drug with a dose less than 10 mg per day; Allowing participants to use topical, ocular, intra articular, intranasal, and inhaled glucocorticoids for treatment.

What they're measuring

Number of participants with adverse events as assessed by CTCAE v5.0

Timeframe: Up to 24 months

Trial details

NCT IDNCT05895370

SponsorBGI, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-13

Contact for this trial

Guiling Li, Doctor

027-85873129 Lg16714@163.com

View on ClinicalTrials.gov More Solid Tumor trials