Brief summary

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.

Inclusion Criteria

Nclusion 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.

Research Center

• Research Center

  The First Affiliated Hospital of Zhengzhou University

• Principal Investigator

  Director Zhang Yi