Clinical Study on the EBV CAR-T /TCR-T Cells in the Treatment of Nasopharyngeal Carcinoma
NCT05587543 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2026-04-02
Summary
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.
Conditions
- Nasopharyngeal Carcinoma
Interventions
- BEHAVIORAL
-
PK Blood Collection
All subjects were subjected to PK blood sampling as prescribed by the protocol.
- DRUG
-
CAR
Target A positive subjects will receive CAR-T cell therapy.
- DRUG
-
TCR
Target A negative, Target B positive and Target C positive subjects will receive TCR-T cell therapy.
Sponsors & Collaborators
-
Fudan University
lead OTHER
Principal Investigators
-
Dongmei Ji, Doctorate · Fudan University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-28
- Primary Completion
- 2027-10-31
- Completion
- 2030-10-31
Countries
- China
Study Locations
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