- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04509726
EBV Specific Cytokine Secreting TCR-T Cells in the Treatment of EBV-Positive Metastatic/Refractory Nasopharyngeal Carcinoma
February 21, 2023 updated by: Qingzhu Jia, M.D., Xinqiao Hospital of Chongqing
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Chongqing
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ChongQing, Chongqing, China, 400037
- Recruiting
- Department of Oncology, Xinqiao Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EBV TCR-T
|
Patients were pre-conditioned with chemotherapy and infused with EBV-specific TCR-T cells with cytokine auto-secreting element
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Maximum Tolerated Dose
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2023
Primary Completion (Anticipated)
August 1, 2023
Study Completion (Anticipated)
August 1, 2023
Study Registration Dates
First Submitted
August 10, 2020
First Submitted That Met QC Criteria
August 10, 2020
First Posted (Actual)
August 12, 2020
Study Record Updates
Last Update Posted (Actual)
February 24, 2023
Last Update Submitted That Met QC Criteria
February 21, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
Other Study ID Numbers
- XQDC20200801
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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