CRTE7A2-01 TCR-T Cell for HPV-16 Positive Advanced Cervical, Anal, or Head and Neck Cancers

Corregene Biotechnology

Status and phase

Enrolling

Phase 1

Conditions

Anal Cancer

Head and Neck Cancers

Cervical Cancer

Treatments

Drug: Interleukin-2

Biological: CRTE7A2-01 TCR-T Cell

Drug: Fludarabine + Cyclophosphamide

Study type

Interventional

Funder types

Industry

Identifiers

NCT05122221

CRTE7A2-2107C

Details and patient eligibility

About

A single center, open, single arm dose escalation phase I study to evaluate the safety, tolerability, and efficacy of CRTE7A2-01 TCR-T cell for HPV16 positive advanced cervical, anal, or head and neck cancers. The study will determine MTD of CRTE7A2-01 TCR-T cell injection, as well as investigate RP2D.

Enrollment

12 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Age ≥18 years and ≤65 years.
Histologically-confirmed cervical cancer, anal cancer, head and neck cancers with confirmed HPV16 infection and HLA-A*02:01 allele
Failure on or intolerance to systemic therapy for unresectable advanced cancer.
ECOG performance status of 0-1.
Estimated life expectancy ≥ 3 months.
Patients must have at least one measurable lesion defined by RECIST 1.1.
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.
The patient must be willing to sign the informed consent form and have a good anticipation of compliance with study procedure.

Exclusion Criteria：

The proportion of T cell immune-related gene deletion mutations>5%.
Patient received any genetically modified T cell therapy.
Patient who is being treated with T cell immunosuppressive agent （such as cyclophosphamide, FK506,tripterygium glycosides） or T cell immunoagonist.
Patients received chemotherapy, targeted therapy, immunotherapy, or other investigational agents within 2 weeks and received radiotherapy within 4 weeks before apheresis.
Patients with any organ dysfuntion 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<0.8 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%
Patients with 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.
Patient with 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 Ⅲ or Ⅳ.
Left Ventricular Ejection Fractions (LVEF) <50%.
Patient with a known active brain metastases.
Patient with a known myelodysplastic syndrome (MDS) or lymphoma.
Patient with 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.
Patient with a known active Hepatitis B or Hepatitis C.
Patient with a history of Human Immunodeficiency Virus (HIV) .
Patient with a history of syphilis.
Pregnant or lactating women.
Patient with a known active mental and neurological diseases.
The principal investigator judged that it is not suitable to participate in this clinical study.