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LMP2-Specific IL12-secreting TCR-T Cells in the Treatment of EBV-Positive Metastatic/Refractory Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT04509726
Recruitment Status : Not yet recruiting
First Posted : August 12, 2020
Last Update Posted : August 12, 2020
Sponsor:
Collaborator:
TCRCure Biopharma Ltd.
Information provided by (Responsible Party):
Qingzhu Jia, M.D., Xinqiao Hospital of Chongqing

Study Description
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Brief 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 LMP2-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. Interleukin 12 (IL-12) seemed to represent the ideal candidate for tumor immunotherapy, due to its ability to activate both innate (NK cells) and adaptive (cytotoxic T lymphocytes) immunities. several clinical studies have been initiated in which IL-12 is applied as an adjuvant in cancer vaccines, in gene therapy including locoregional injections of IL-12 plasmid and in the form of tumor-targeting immunocytokines (IL-12 fused to monoclonal antibodies). Therefore, TCR-T cells armed with a IL12-secretion element could further enhance the efficacy of TCR-T in solid cancers.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: LMBP2-specific TCR-T cell with IL12 auto-secreting element Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-Arm Trial of LMP2-Specific TCR-T Cells With IL12 Auto-secreted Element in the Treatment of EBV-Positive Head and Neck Carcinoma Metastatic/Refractory Nasopharyngeal Carcinoma
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: EBV TCR-T Drug: LMBP2-specific TCR-T cell with IL12 auto-secreting element
Patients were pre-conditioned with chemotherapy and infused with LBMP2-specific TCR-T cells with IL12 auto-secreting element


Outcome Measures
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Primary Outcome Measures :
  1. The Maximum Tolerated Dose [ Time Frame: 8 weeks ]
    Verify the MTD of TCR-T cells for LMP2 antigen for treatment. The first nine patients enrolled in this project will be infused in a dose-climbing approach, with every three patients as a group. The first group of patients returned to 5e+6/kg TCR-T cells, the second group returned to 1e+7/kg TCR-T cells, and the third group returned to 5e+7/kg TCR-T cells. The remaining 11 patients will infused with TCR-Ts in the maximum tolerated dose


Eligibility Criteria
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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
Criteria

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 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
Contacts and Locations
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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): NCT04509726


Locations
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China, Chongqing
Department of Oncology, Xinqiao Hospital
ChongQing, Chongqing, China, 400037
Sponsors and Collaborators
Xinqiao Hospital of Chongqing
TCRCure Biopharma Ltd.
More Information
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Responsible Party: Qingzhu Jia, M.D., Doctor, Xinqiao Hospital of Chongqing
ClinicalTrials.gov Identifier: NCT04509726    
Other Study ID Numbers: XQDC20200801
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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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Carcinoma
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
 Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases