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EBV-Specific Anti-PD1 TCR-T Cells in the Treatment of EBV-Positive NHSCC

Primary Purpose

Head and Neck Squamous Cell Carcinoma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
EBV-specific TCR-T cell with anti-PD1 auto-secreted element
Sponsored by
Xinqiao Hospital of Chongqing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Oncology, Xinqiao HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EBV TCR-T

Arm Description

EBV-specific TCR-T cell with anti-PD1 auto-secreted element

Outcomes

Primary Outcome Measures

The Maximum Tolerated Dose
Verify the MTD of TCR-T cells for EBV antigen for treatment. 18 patients will be enrolled in this project, using a dose-escalation approach. The first group of patients will receive 5x10e6/kg TCR-T cells, the second group will receive 1x10e7/kg TCR-T cells, the third group will receive 5x10e7/kg TCR-T cells, the forth group will receive 1x10e8/kg. After confirmation of safety for 5×10e7 dose group, we then added IL-2 on this dose level for consecutive 6 patients. The remaining 6 pts are for enrollment of 1×10e8/kg dose level.

Secondary Outcome Measures

Full Information

First Posted
October 23, 2019
Last Updated
February 13, 2023
Sponsor
Xinqiao Hospital of Chongqing
Collaborators
TCRCure Biopharma Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04139057
Brief Title
EBV-Specific Anti-PD1 TCR-T Cells in the Treatment of EBV-Positive NHSCC
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinqiao Hospital of Chongqing
Collaborators
TCRCure Biopharma Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EBV TCR-T
Arm Type
Experimental
Arm Description
EBV-specific TCR-T cell with anti-PD1 auto-secreted element
Intervention Type
Drug
Intervention Name(s)
EBV-specific TCR-T cell with anti-PD1 auto-secreted element
Intervention Description
Patients were pre-conditioned with chemotherapy and infused with EBV-specific TCR-T cells with anti-PD1 auto-secreted element
Primary Outcome Measure Information:
Title
The Maximum Tolerated Dose
Description
Verify the MTD of TCR-T cells for EBV antigen for treatment. 18 patients will be enrolled in this project, using a dose-escalation approach. The first group of patients will receive 5x10e6/kg TCR-T cells, the second group will receive 1x10e7/kg TCR-T cells, the third group will receive 5x10e7/kg TCR-T cells, the forth group will receive 1x10e8/kg. After confirmation of safety for 5×10e7 dose group, we then added IL-2 on this dose level for consecutive 6 patients. The remaining 6 pts are for enrollment of 1×10e8/kg dose level.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qingzhu Jia, MD
Phone
15223334184
Ext
13647614555
Email
jiaqingzhu0801@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Zhu, MD, PhD
Organizational Affiliation
Army Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oncology, Xinqiao Hospital
City
ChongQing
State/Province
Chongqing
ZIP/Postal Code
400037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingzhu Jia, MD
Phone
152-2333-4184
Ext
+86
Email
jiaqinghzu0801@outlook.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

EBV-Specific Anti-PD1 TCR-T Cells in the Treatment of EBV-Positive NHSCC

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