| Eligibility |
Inclusion Criteria:
1. Greater than or equal to 18 years of age and less than or equal to 75 years of age;
all genders.
2. Confirmed diagnosis of recurrent of metastatic solid tumor and at least one measurable
lesion.
3. HLA type is HLA-A0201.
4. HPV 16 positive.
5. Patients who failed or were intolerant to standard first-line treatment.
6. Possess venous access for mononuclear cell collection or intravenous blood collection.
7. Clinical performance status of ECOG is 0 or 1.
8. Possess venous access for mononuclear cell collection or intravenous blood collection.
9. Patients who are able to cooperate to observe adverse reactions and the effect of the
treatment,expected lifetime is greater than six month.
10. Patients of both genders must be willing to practice birth control from the time of
enrollment to three months after treatment on this study,a fertile woman must have a
negative pregnancy test.
11. The laboratory test values and the functions of important organs meet the following
requirements:
1#Serology: HIV antibody(-), hepatitis B DNA(-), hepatitis C antibody(-) and no active
syphilis infection; 2#Hematology: Absolute neutrophil count is greater than or equal to
1.5×10^9/L; WBC is greater than or equal to 3×10^9/L; lymphocyte count is greater than or
equal to 0.8×10^9/L; Platelet count is greater than or equal to 100×10^9/L; Hemoglobin is
greater than or equal to 85g/L ; 3#Chemistry: Serum ALT/AST is less than or equal to 3
times ULN,except in patients with liver metastasis who must have ALT/AST less than or equal
to 5 times ULN; Serum Creatinine is less than or equal to 1.5 times ULN ; Total bilirubin
is less than or equal to 1.5 times ULN, except in patients with Gilbert's Syndrome who must
have a total bilirubin less than 3 times ULN; 4#Blood Clotting Parameters:Prothrombin
Time(PT) and International Normalised Ratio (INR) are less than or equal to 1.5 times
ULN;Activated Partial Thromboplastin Time (APTT) is less than or equal to 1.5 times ULN;For
subjects who frequently take anticoagulant drugs,their blood clotting parameters can meet
the value range adoptive to this special population; 5#Left ventricular ejection
fraction#LVEF#is more than or equal to 50%. 12. More than four weeks must have elapsed
since any prior systemic therapy (except for bridging therapy) at the time the patient
receives the lymphodepletion regimen, and toxicities must have recovered to grade 1 or less
(except for toxicities such as alopecia or vitiligo)
Exclusion Criteria:
1. Pregnant or lactating women.
2. History of severe immediate hypersensitivity reaction to HPV-T and any of the agents
used in this study.
3. Participants with a history of organ transplantation.
4. Participants with brain metastases.
5. 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.
6. Active systemic infections, for example, acute infections requiring systemic
antibiotic, antiviral, or antifungal treatment occur within 2 weeks before enrollment.
7. 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.
8. 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.
9. Participants plan to receive immunomodulatory drugs (such as interferon, GM-CSF,
thymosin, gamma globulin, excluding IL-2) within 4 weeks before the administration of
lymphocyte clearance.
10. The investigator assessed that the subject was unable or unwilling to comply with the
requirements of the study protocol.
11. With a history of other malignant tumors.
12. The participant has any disease or medical condition that may affect the safety or
effectiveness evaluation of the study treatment.
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