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HPV-E6-Specific Anti-PD1 TCR-T Cells in the Treatment of HPV-Positive NHSCC or Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03578406
Recruitment Status : Unknown
Verified April 2019 by Qingzhu Jia, M.D., Xinqiao Hospital of Chongqing.
Recruitment status was:  Recruiting
First Posted : July 6, 2018
Last Update Posted : May 1, 2019
TCRCure Biopharma Ltd.
Information provided by (Responsible Party):
Qingzhu Jia, M.D., Xinqiao Hospital of Chongqing

Brief Summary:
Human papillomavirus infections 16 (HPV16) is known to be a high-risk factor to induce cervical cancers. To date, HPV16-related cervical cancer is still a major concern in developing countries where vaccination is not prevalent. Concurrent therapies for cervical cancers have limited response rate and high chance of relapse. However, HPV16-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 HPV 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
Cervical Cancer Head and Neck Squamous Cell Carcinoma Drug: HPV E6-specific TCR-T cells Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Two-Arm Open-Labeled Trial of HPV-E6-Specific TCR-T Cells With or Without Anti-PD1 Auto-secreted Element in the Treatment of HPV-Positive Head and Neck Carcinoma or Cervical Cancer
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: HPV TCR-T
HPV E6-specific TCR-T cell
Drug: HPV E6-specific TCR-T cells
Patients were infused with HPV E6-specific TCR-T cells

Experimental: HPV TCR-T with anti-PD1
HPV E6-specific TCR-T cell with anti-PD1 auto-secreted element
Drug: HPV E6-specific TCR-T cells
Patients were infused with HPV E6-specific TCR-T cells

Primary Outcome Measures :
  1. To Determine the Maximum Tolerated Dose [ Time Frame: 8 weeks ]
    Verify the MTD of TCR-T cells for HPV16 E6 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

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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 HPV16 positive malignant tumor, 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): NCT03578406

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Contact: Qingzhu Jia +8615223334184 ext +8615223334184 jiaqingzhu0801@outlook.com

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China, Chongqing
Qingzhu Jia Recruiting
Chongqing, Chongqing, China, 400037
Contact: Qingzhu Jia    +8615223334184 ext +8615223334184    jiaqingzhu0801@outlook.com   
Sponsors and Collaborators
Xinqiao Hospital of Chongqing
TCRCure Biopharma Ltd.
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Principal Investigator: Bo Zhu Oncology of Department, Xinqiao Hospital
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Responsible Party: Qingzhu Jia, M.D., Secretary of Research, Xinqiao Hospital of Chongqing
ClinicalTrials.gov Identifier: NCT03578406    
Other Study ID Numbers: XQDC20180520
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019

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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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Uterine Cervical Neoplasms
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Head and Neck Neoplasms