HPV16 E6 TCR T Cells for Cervical Carcinoma

Inclusion Criteria:

1. Be able to understand and sign the Informed of Consent Document. Be willing to followthe procedure and protocol of the clinical trial.
2. Age ≥ 18 years and ≤ 70 years.
3. Expected survival time > 3 months.
4. ECOG score 0-1.
5. Recurrent or metastatic cervical carcinoma based on TNM & FIGO stagedhistopathological investigation.
6. Received at least second-line standard treatment and diagnosed as PD through imageassessment. (previously received radio-therapy, chemo-therapy, targeted-therapy orimmune-therapy, wash-out period > 14 or 5 half life)
7. Be able provide fresh or preserved tissue specimen. (fresh specimen first, paraffinespecimen or at least 12 tumor section, tumor tissue >20%)
8. At least 1 measurable lesion (according to RECIST1.1 standard）.
9. HPV16 positive.
10. HLA-A2 positive.
11. Hematology should at least meet the following criteria: Absolute neutrophil count (ANC) ≥ 1.5× 109/L (±20%)； Platelet (PLT） ≥ 75× 109/L (±20%）； Hemoglobin (HGB) ≥ 90 g/L (±20%).
12. Blood biochemistry should at least meet the following criteria: Serum creatinine (Cr) ≤ 1.5 times of upper limit of normal (ULN) or creatine clearance ≥ 60 ml/min; Serum Alanine aminotransferase (ALT) or/and Aspartate aminotransferase (AST) ≤ 2.5 times of upper limit of normal; Total bilirubin (TBIL) ≤ 15 times of upperlimit of normal.
13. Blood coagulation function is normal: Prothrombin time (PT) ≤ 1.5 ULN, InternationalNormalized Ratio (INR) ≤ 1.5 ULN, or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 ULN.
14. Women of childbearing potential should be ascetic or take contraception since thesigning of ICF to 24 weeks or later after the last administration of drug.
15. Recovered from toxic effect of previous treatment (CTCAE ≤ 1), or related AE(s) is notdefined as safety issue.
16. Catheter insertion is feasible and No White Blood Cells collection contraindications.

Exclusion Criteria:

1. Under pregnancy or lactation, or positive based on blood pregnancy test.
2. Severe allergic to related ingredients in the clinical trial.
3. Received any other investigational treatment within 4 weeks before the firstadministration or enrolled in another clinical trial the same time (exception: theother treatment is observational and non-investigational or the patient is underfollow-up period)
4. Primary central nerve system (CNS) cancer, or subjects with CNS metastasis afterlocalized treatment (except patients without CNS metastasis, clinically stable andneither steroid treatment nor treatment for CNS metastasis).
5. Patients with active autoimmune disease or require systemic steroid treatment. (exceptpatients with cutaneous condition but without systemic treatment, or subjects withasthma in childhood but without intervention after grown-up, or subjects withhypothyroidism mediated by autoimmune dysfunction and receiving thyroxine as replacedtreatment)
6. Immunodeficiency including HIV positive, harvested or natural immunodeficiency.
7. Patients with ≥ grade 3 thromboembolic events within 2 years or under thrombolysistreatment.
8. Patients with hereditary or acquired hemorrhagic disease
9. Patients with cardiovascular disease or symptoms: congestive heart failure (NYHA > 2); history of unstable angina pectoris; miocardialinfarction within 48 weeks; clinically significant malignant arrhythmia (except atrialfibrillation and paroxysmal supraventricular tachycardia); Clinically significantprolonged QTcF (Male QTcF > 450 msec, Female QTcF > 470 msec); Uncontrolledhypertension.
10. Patients under active infection (except subjects with fever caused by tumor)
11. Patients with active tuberculosis, or history of active tuberculosis within 1 yearbefore enrollment, or history of active tuberculosis over a year before enrollment butwithout standard treatment.
12. Patient with Active Hepatitis B or Active Hepatitis C.
13. Treponema pallidum antibody positive.
14. Received major surgery or under severe injury within 4 weeks before enrollment.
15. History of drug abuse, alcohol or drug addiction.
16. Received cell therapy before enrollment，such as TCR-T，CAR-T and TIL .
17. Allergic to IL-2.
18. Received treatment related chemo-therapy within 14 days of TC-E202 infusion (exceptlymphodepletion) .
19. Patient not suitable for the clinical trial according to investigators.