Treatment of EBV-positive nasopharyngeal carcinoma using engineered T cells
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
This study is testing a new treatment using specially modified immune cells to see if they can help people with advanced nasopharyngeal cancer caused by the Epstein-Barr virus.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Xinqiao Hospital of Chongqing Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (ChongQing, Chongqing) |
| Trial ID | NCT04509726 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of engineered T cells that specifically target Epstein-Barr virus (EBV) in patients with metastatic or refractory nasopharyngeal carcinoma (NPC). The approach involves T cells that are modified to secrete cytokines, enhancing their ability to activate the immune response against the cancer. The trial aims to evaluate the safety and efficacy of these TCR-T cells in a population that has limited treatment options due to the aggressive nature of the disease. Participants will be monitored for their response to the treatment and any potential side effects.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with confirmed EBV-positive nasopharyngeal carcinoma who have metastatic or recurrent disease and are expected to live longer than 12 weeks.
Not a fit: Patients with symptomatic brain metastasis or other uncontrolled malignancies, as well as those with severe comorbid conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with EBV-positive nasopharyngeal carcinoma, potentially improving survival rates and quality of life.
How similar studies have performed: While engineered T cell therapies have shown promise in hematological cancers, their application in solid tumors like nasopharyngeal carcinoma is still being explored, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
ChongQing, Chongqing
- Department of Oncology, Xinqiao Hospital — ChongQing, Chongqing, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.