Clinical Study on the EBV CAR-T /TCR-T Cells in the Treatment of Nasopharyngeal Carcinoma
ConditionNasopharyngeal Carcinoma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University
About this trial
This study was a single-arm, open-label, "3 + 3" dose-escalation Exploratory research. The patients were divided into two groups: EBV TCR-T-cell Group and EBV CAR-T-cell group. The EBV CAR-T-treated group received three progressively increasing dose levels (3.0 × 106 cells/kg, 9.0 × 106 cells/kg, 1.5 × 107 cells/kg) of EBV CAR-T-cell therapy; The EBV TCR-T-cell group received three progressively increasing doses (5.0 × 106 cells/kg, 1.5 × 107 cells/kg, 3.0 × 107 cells/kg) of EBV TCR-T-cell therapy.
Eligibility criteria
Qualifiers
Voluntary written informed consent;
Age ≥18 years old, ≤75 years old, male and female;
Expected survival ≥3 months;
The Eastern Cooperative Oncology Group (ECOG) physical fitness score was 0-2;
Disqualifiers
Active central nervous system metastases (except those that are stable after treatment)；
HIV positive, HBsAg positive and HBV DNA copy number positive (quantitative detection ≥1000 CPS/ml) , HCV antibody positive and HCV RNA positive;
Patients with mental or psychological disorders who can not cooperate with the treatment and evaluation of the curative effect;
Subjects with severe autoimmune disease and long-term use of immunosuppressants;
Trial design
Treatments tested in this trial
- PK Blood Collection
- CAR
- TCR
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov