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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

PK Blood Collection
Behavioral
All subjects were subjected to PK blood sampling as prescribed by the protocol.
CAR
Drug
Target A positive subjects will receive CAR-T cell therapy.
TCR
Drug
Target A negative, Target B positive and Target C positive subjects will receive TCR-T cell therapy.

Treatment groups

24 Participants

are divided into 2 treatment groups

Group A: CAR-TExperimental treatment 2 interventions

Group B: TCR-TExperimental treatment 2 interventions