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Trial record 6 of 43 for:    TCR-T

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

Tracking Information
First Submitted Date  ICMJE August 10, 2020
First Posted Date  ICMJE August 12, 2020
Last Update Posted Date August 12, 2020
Estimated Study Start Date  ICMJE September 2020
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE LMP2-Specific IL12-secreting TCR-T Cells in the Treatment of EBV-Positive Metastatic/Refractory Nasopharyngeal Carcinoma
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nasopharyngeal Carcinoma
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: EBV TCR-T
Intervention: Drug: LMBP2-specific TCR-T cell with IL12 auto-secreting element
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 10, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2023
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04509726
Other Study ID Numbers  ICMJE XQDC20200801
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Qingzhu Jia, M.D., Xinqiao Hospital of Chongqing
Study Sponsor  ICMJE Xinqiao Hospital of Chongqing
Collaborators  ICMJE TCRCure Biopharma Ltd
Investigators  ICMJE Not Provided
PRS Account Xinqiao Hospital of Chongqing
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP