HPV-E6-Specific Anti-PD1 TCR-T Cells in the Treatment of HPV-Positive NHSCC or Cervical Cancer

Human papillomavirus infections 16 (HPV16) is known to be a high-risk factor to induce cervical cancers. To date, HPV16-related cervical cancer is still a major concern in developing countries where vaccination is not prevalent. Concurrent therapies for cervical cancers have limited response rate and high chance of relapse. However, HPV16-induced cancers provided an ideal target for T cell-based immunotherapy due to the non-self origins. Engineered T cells bearing a TCR (TCR-T) that can specifically recognize the presented HPV antigen become a viable approach to treat this type of cancer. Though engineered T therapies have been well-recognized in hematological cancers, solid cancer treatment has been a major hurdle due to the immune-suppressive tumor microenvironment. One key mechanism of tumor-elicited suppression is the PDL1-PD1 interaction which induces T cell exhaustion. Therefore, TCR-T cells armed with a PD1 antagonist could further enhance the efficacy of TCR-T in solid cancers.

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Key information

Conditions

Cervical Cancer Carcinoma Carcinoma, Squamous Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Head and Neck Neoplasms Head and Neck Squamous Cell Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Qingzhu Jia

Chongqing, Chongqing Municipality, 400037, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Expected to live longer than 12 weeks
PS 0-2
Pathology confirmed as HPV16 positive malignant tumor, either metastatic or recurrent disease
Creatinine <2.5mg/dl
ALT/AST is lower than three times ULN.
No contraindications of leukocyte collection
Before entering the trial, women must adopt a reliable method of contraception until 30 days after infusion.
Understand this trial and have signed an informed consent

Exclusion criteria

Patients with symptomatic brain metastasis
With other uncontrolled malignant tumors.
Hepatitis B or Hepatitis C activity period, HIV infected patients
Any other uncontrolled disease that interferes with the trial
Patients with severe heart and cerebrovascular diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis and cerebral hemorrhage
Untreated hypertension or hypertensive patients
A person with a history of mental illness that is difficult to control
Researchers do not consider it appropriate to participate in this trial
Patients who have been using immunosuppressive agents for a long time after organ transplants, except for recent or current inhaled corticosteroids
Subjects who have been pregnant or nursing, or who plan for pregnancy within 2 months of treatment or after the end of treatment
An illness affects a person who signs a written consent or complies with a study procedure, or who is unwilling or unable to comply with the research requirements

Treatment and study plan

HPV E6-specific TCR-T cells

Drug

Patients were infused with HPV E6-specific TCR-T cells

Primary outcomes

To Determine the Maximum Tolerated Dose

Time frame: 8 weeks

Verify the MTD of TCR-T cells for HPV16 E6 antigen for treatment. Nine patients will be enrolled in this project, using a dose-climbing approach, with every three patients as a group. The first group of patients returned to 5x106/kg TCR-T cells, the second group returned to 1x107/kg TCR-T cells, and the third group returned to 5x107/kg TCR-T cells

Sponsors and collaborators

Lead sponsor

Xinqiao Hospital of Chongqing

Other

Collaborators

TCRCure Biopharma Ltd.

Registry information

Official study title

Two-Arm Open-Labeled Trial of HPV-E6-Specific TCR-T Cells With or Without Anti-PD1 Auto-secreted Element in the Treatment of HPV-Positive Head and Neck Carcinoma or Cervical Cancer

Important dates

Study start: 2018
Primary completion: 2022
Study completion: 2022
First posted: Jul 6, 2018
Registry last updated: Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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