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Trial record 1 of 1 for:    NCT04139057
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EBV-Specific Anti-PD1 TCR-T Cells in the Treatment of EBV-Positive NHSCC

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ClinicalTrials.gov Identifier: NCT04139057
Recruitment Status : Unknown
Verified November 2020 by Qingzhu Jia, M.D., Xinqiao Hospital of Chongqing.
Recruitment status was:  Recruiting
First Posted : October 25, 2019
Last Update Posted : November 18, 2020
TCRCure Biopharma Ltd.
Information provided by (Responsible Party):
Qingzhu Jia, M.D., Xinqiao Hospital of Chongqing

Brief 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.

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Drug: EBV-specific TCR-T cell with anti-PD1 auto-secreted element Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-Arm Trial of EBV-Specific TCR-T Cells With Anti-PD1 Auto-secreted Element in the Treatment of EBV-Positive Head and Neck Carcinoma
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: EBV TCR-T
EBV-specific TCR-T cell with anti-PD1 auto-secreted element
Drug: EBV-specific TCR-T cell with anti-PD1 auto-secreted element
Patients were pre-conditioned with chemotherapy and infused with EBV-specific TCR-T cells with anti-PD1 auto-secreted element

Primary Outcome Measures :
  1. The Maximum Tolerated Dose [ Time Frame: 8 weeks ]
    Verify the MTD of TCR-T cells for EBV 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04139057

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Contact: Qingzhu Jia, MD 15223334184 ext 13647614555 jiaqingzhu0801@outlook.com

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China, Chongqing
Department of Oncology, Xinqiao Hospital Recruiting
ChongQing, Chongqing, China, 400037
Contact: Qingzhu Jia, MD    152-2333-4184 ext +86    jiaqinghzu0801@outlook.com   
Sponsors and Collaborators
Xinqiao Hospital of Chongqing
TCRCure Biopharma Ltd.
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Principal Investigator: Bo Zhu, MD, PhD Army Medical University
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Responsible Party: Qingzhu Jia, M.D., Doctor, Xinqiao Hospital of Chongqing
ClinicalTrials.gov Identifier: NCT04139057    
Other Study ID Numbers: XQDC20191001
First Posted: October 25, 2019    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site