Status:
RECRUITING
HPV16 E6 TCR T Cells for Cervical Carcinoma
Lead Sponsor:
TCRCure Biopharma Ltd.
Collaborating Sponsors:
Fudan University
Conditions:
Cervical Carcinoma
Eligibility:
FEMALE
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Background: Cervical cancer is the most common gynecologic malignant tumor. The occurrence and progression of cervical carcinoma is firmly relevant to HPV (Human papilloma virus) infection. Cancer ce...
Detailed Description
Background: Cervical cancer is the most common gynecologic malignant tumor. The occurrence and progression of cervical carcinoma is firmly relevant to HPV (Human papilloma virus) infection. Cancer c...
Eligibility Criteria
Inclusion
- Be able to understand and sign the Informed of Consent Document. Be willing to follow the procedure and protocol of the clinical trial.
- Age ≥ 18 years and ≤ 70 years.
- Expected survival time \> 3 months.
- ECOG score 0-1.
- Recurrent or metastatic cervical carcinoma based on TNM \& FIGO staged histopathological investigation.
- Received at least second-line standard treatment and diagnosed as PD through image assessment. (previously received radio-therapy, chemo-therapy, targeted-therapy or immune-therapy, wash-out period \> 14 or 5 half life)
- Be able provide fresh or preserved tissue specimen. (fresh specimen first, paraffine specimen or at least 12 tumor section, tumor tissue \>20%)
- At least 1 measurable lesion (according to RECIST1.1 standard）.
- HPV16 positive.
- HLA-A2 positive.
- 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%).
- 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 upper limit of normal.
- Blood coagulation function is normal: Prothrombin time (PT) ≤ 1.5 ULN, International Normalized Ratio (INR) ≤ 1.5 ULN, or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 ULN.
- Women of childbearing potential should be ascetic or take contraception since the signing of ICF to 24 weeks or later after the last administration of drug.
- Recovered from toxic effect of previous treatment (CTCAE ≤ 1), or related AE(s) is not defined as safety issue.
- Catheter insertion is feasible and No White Blood Cells collection contraindications.
Exclusion
- Under pregnancy or lactation, or positive based on blood pregnancy test.
- Severe allergic to related ingredients in the clinical trial.
- Received any other investigational treatment within 4 weeks before the first administration or enrolled in another clinical trial the same time (exception: the other treatment is observational and non-investigational or the patient is under follow-up period)
- Primary central nerve system (CNS) cancer, or subjects with CNS metastasis after localized treatment (except patients without CNS metastasis, clinically stable and neither steroid treatment nor treatment for CNS metastasis).
- Patients with active autoimmune disease or require systemic steroid treatment. (except patients with cutaneous condition but without systemic treatment, or subjects with asthma in childhood but without intervention after grown-up, or subjects with hypothyroidism mediated by autoimmune dysfunction and receiving thyroxine as replaced treatment)
- Immunodeficiency including HIV positive, harvested or natural immunodeficiency.
- Patients with ≥ grade 3 thromboembolic events within 2 years or under thrombolysis treatment.
- Patients with hereditary or acquired hemorrhagic disease
- Patients with cardiovascular disease or symptoms:
- congestive heart failure (NYHA \> 2); history of unstable angina pectoris; miocardial infarction within 48 weeks; clinically significant malignant arrhythmia (except atrial fibrillation and paroxysmal supraventricular tachycardia); Clinically significant prolonged QTcF (Male QTcF \> 450 msec, Female QTcF \> 470 msec); Uncontrolled hypertension.
- Patients under active infection (except subjects with fever caused by tumor)
- Patients with active tuberculosis, or history of active tuberculosis within 1 year before enrollment, or history of active tuberculosis over a year before enrollment but without standard treatment.
- Patient with Active Hepatitis B or Active Hepatitis C.
- Treponema pallidum antibody positive.
- Received major surgery or under severe injury within 4 weeks before enrollment.
- History of drug abuse, alcohol or drug addiction.
- Received cell therapy before enrollment，such as TCR-T，CAR-T and TIL .
- Allergic to IL-2.
- Received treatment related chemo-therapy within 14 days of TC-E202 infusion (except lymphodepletion) .
- Patient not suitable for the clinical trial according to investigators.
Key Trial Info
Start Date :
August 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05357027
Start Date
August 10 2022
End Date
August 31 2025
Last Update
April 12 2024
Active Locations (1)
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1
Xiaochun Cheng
Chongqing, Chongqing Municipality, China, 400000