Overview

EBV-Specific Anti-PD1 TCR-T Cells in the Treatment of EBV-Positive NHSCC

Status:
Recruiting
Trial end date:
2022-02-28
Target enrollment:
0
Participant gender:
All
Summary
Epstein-Barr virus (EBV) infections is known to be a high-risk factor to induce nasopharyngeal cancers. To date, EBV-related head and neck squamous cell carcinoma (HNSCC) is still a major concern in east Asia, especially in China. Concurrent therapies for HNSCC have limited response rate and high chance of relapse. However, EBV-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 EBV 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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Xinqiao Hospital of Chongqing
Collaborator:
TCRCure Biopharma Ltd
Criteria
Inclusion Criteria:

- Expected to live longer than 12 weeks

- PS 0-2

- Pathology confirmed as EBV positive HNSCC, 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