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EBV Specific Cytokine Secreting TCR-T Cells in the Treatment of EBV-Positive Metastatic/Refractory Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

EBV-specific TCR-T cell with cytokine auto-secreting element

About this trial

This is an interventional treatment trial for Nasopharyngeal 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 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

Sites / Locations

Department of Oncology, Xinqiao HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EBV TCR-T

Arm Description

Outcomes

Primary Outcome Measures

The Maximum Tolerated Dose

Verify the MTD of TCR-T cells for EBV antigen for treatment. The first nine patients enrolled in this project will be infused in a dose-escalation approach. The first group of patients will receive 5e+6/kg TCR-T cells, the second group will receive 1e+7/kg TCR-T cells, and the third group will receive 5e+7/kg TCR-T cells. The remaining 11 patients will be infused with TCR-Ts in the maximum tolerated dose.

Secondary Outcome Measures

Full Information

NCT ID

NCT04509726

First Posted

August 10, 2020

Last Updated

February 21, 2023

Sponsor

Xinqiao Hospital of Chongqing

Collaborators

TCRCure Biopharma Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04509726

Brief Title

EBV Specific Cytokine Secreting TCR-T Cells in the Treatment of EBV-Positive Metastatic/Refractory Nasopharyngeal Carcinoma

Official Title

Single-Arm Trial of EBV Specific Cytokine Secreting TCR-T Cells in the Treatment of EBV-Positive Head and Neck Carcinoma Metastatic/Refractory Nasopharyngeal Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 2023 (Anticipated)

Primary Completion Date

August 2023 (Anticipated)

Study Completion Date

August 2023 (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 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 EBV-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. Cytokine seemed to represent the ideal candidate for tumor immunotherapy, due to its ability to activate both innate (NK cells) and adaptive immunities. therefore, TCR-T cells armed with a cytokine -secretion element 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

Nasopharyngeal 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

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

EBV TCR-T

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

EBV-specific TCR-T cell with cytokine auto-secreting element

Intervention Description

Patients were pre-conditioned with chemotherapy and infused with EBV-specific TCR-T cells with cytokine auto-secreting 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 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

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

Undecided

Learn more about this trial

EBV Specific Cytokine Secreting TCR-T Cells in the Treatment of EBV-Positive Metastatic/Refractory Nasopharyngeal Carcinoma

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