EBV Specific Cytokine Secreting TCR-T Cells in the Treatment of EBV-Positive Metastatic/Refractory Nasopharyngeal Carcinoma

Last updated: October 22, 2024
Sponsor: Xinqiao Hospital of Chongqing
Overall Status: Active - Recruiting

Phase

1/2

Condition

Carcinoma

Nasopharyngeal Cancer

Treatment

EBV-specific TCR-T cell with cytokine auto-secreting element

Clinical Study ID

NCT04509726
XQDC20200801
  • Ages 18-70
  • All Genders

Study Summary

Epstein-Barr virus (EBV) infections is known to be a high-risk factor to induce cervical cancers. To date, EBV-related nasopharyngeal carcinoma (NPC) is still a major concern in east Asia, especially in China. Concurrent therapies for NPC 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-epitope 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. Cytokine seemed to represent the ideal candidate for tumor immunotherapy, due to its ability to activate both innate (NK cells) and adaptive immunities. therefore, TCR-T cells armed with a cytokine -secretion element could further enhance the efficacy of TCR-T in solid cancers.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Expected to live longer than 12 weeks

  • PS 0-2

  • Pathology confirmed as EBV positive NPC, 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

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 heartdisease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis andcerebral 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 organtransplants, except for recent or current inhaled corticosteroids

  • Subjects who have been pregnant or nursing, or who plan for pregnancy within 2months of treatment or after the end of treatment

  • An illness affects a person who signs a written consent or complies with a studyprocedure, or who is unwilling or unable to comply with the research requirements

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: EBV-specific TCR-T cell with cytokine auto-secreting element
Phase: 1/2
Study Start date:
March 01, 2023
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Department of Oncology, Xinqiao Hospital

    ChongQing, Chongqing 400037
    China

    Active - Recruiting

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