Status:
RECRUITING
EBV Specific Cytokine Secreting TCR-T Cells in the Treatment of EBV-Positive Metastatic/Refractory Nasopharyngeal Carcinoma
Lead Sponsor:
Xinqiao Hospital of Chongqing
Collaborating Sponsors:
TCRCure Biopharma Ltd.
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04509726
Start Date
March 1 2023
End Date
December 1 2024
Last Update
October 23 2024
Active Locations (1)
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1
Department of Oncology, Xinqiao Hospital
Chongqing, Chongqing Municipality, China, 400037