| Eligibility |
Inclusion Criteria:
1. Age >18 years and 65 years. 2. Patients with advanced solid tumors (such as cervical
cancer, head and neck tumors, anal cancer, and other malignancies) who have failed standard
treatment confirmed by histology and/or cytology, or who are intolerant to such treatment,
and for whom there is no effective therapy available after standard treatment failure are
considered as end-stage patients. Specifically for:
1. Cervical cancer: a) Patients who have previously failed at least second-line systemic
therapy (including at least one platinum-based regimen or anti-angiogenic therapy) and
have shown disease progression or intolerance confirmed by pathological or
radiological examination during or after the most recent treatment course, and are not
amenable to treatment with surgery or radiotherapy, with no standard treatment options
currently available for recurrent or metastatic cervical cancer.
2. Nasopharyngeal cancer: a) Patients who have previously failed at least third-line
systemic therapy or are intolerant, not amenable to treatment with surgery or
radiotherapy, with no standard treatment options currently available for recurrent or
metastatic nasopharyngeal cancer; b) EB virus negative.
3. Head and neck squamous cell carcinoma: a) Patients who have previously failed at least
second-line systemic therapy or are intolerant, with no standard treatment options
currently available for recurrent or metastatic head and neck squamous cell carcinoma
(non-nasal).
3. Confirmation of HPV16 positive and HLA-A*02:01 allele. 4. ECOG performance status of
0-1. 5. Estimated life expectancy = 3 months. 6. Patients must have at least one measurable
lesion defined by RECIST 1.1. 7. Female patients of childbearing age must undergo a serum
pregnancy test within 7 days prior to study treatment and the results must be negative, and
are willing to use a very effective and reliable method of contraception from screening
through 6 months after the last dose of study treatment.
8. The patient must be willing to sign the informed consent form and have a good
anticipation of compliance with study procedure.
Exclusion Criteria:
1. Patient received any genetically modified T cell therapy.
2. Patient is being treated with T cell immunosuppressive agent (such as
cyclophosphamide, FK506,tripterygium glycosides) or T cell immunoagonist.
3. Patients received chemotherapy, targeted therapy, immunotherapy, or other
investigational agents within 2 weeks and received radiotherapy within 4 weeks before
apheresis.
4. Patients have any organ system function impairment as defined below:
- leukocytes<3.0 x 109/L
- absolute neutrophil count >1.5 x 109/L
- hemoglobin<90g/L
- platelets <100 x 1010/L
- lymphocytes<0.5 x 109/L
- percentage of lymphocytes<15%
- creatinine>1.5×ULN or creatinine clearance <50mL/min
- total bilirubin>3×ULN; ALT/AST>3×ULN (patients with liver metastasis,>5×ULN)
- INR>1.5×ULN; APTT>1.5×ULN
- SpO2=90%
6. Patinets has serious medical conditions, disorders, and / or comorbidities, including,
but are not limited to: severe heart disease, cerebrovascular disease, epileptic seizures,
uncontrolled diabetes (CTCAE 5.0: FBG = 2 grade), active infection, active digestive tract
Ulcer, gastrointestinal bleeding, intestinal obstruction, pulmonary fibrosis, renal
failure, respiratory failure.
7. Patient has a severe cardiovascular disease with 6 months before screening, including,
but are not limited to, myocardial infarction, severe or unstable angina, coronary or
peripheral artery bypass grafting, Heart failure NYHA grade ? or ?.
8. Left Ventricular Ejection Fractions (LVEF) <50%. 9. Patient has a known active brain
metastases. 10. Patient has a known myelodysplastic syndrome (MDS) or lymphoma. 11. Patient
has a known active autoimmune disease, including , but are not limited to, acquired or
congenital immunodeficiency disease, allogeneic organ transplantation, autoimmune
hepatitis, systemic lupus erythematosus, inflammatory bowel disease.
12. Patient has a known active Hepatitis B or Hepatitis C. 13. Patient has a history of
Human Immunodeficiency Virus (HIV) . 14. Patient has a history of syphilis. 15. Pregnant or
lactating women. 16. Patient has a known active mental and neurological diseases. 17. The
principal investigator judged that it is not suitable to participate in this clinical
study.
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