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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

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

NCT ID

NCT04139057

First Posted

October 23, 2019

Last Updated

February 13, 2023

Sponsor

Xinqiao Hospital of Chongqing

Collaborators

TCRCure Biopharma Ltd.

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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

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

jiaqinghzu0801@outlook.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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