NCT05587543

Clinical Study on the EBV CAR-T /TCR-T Cells in the Treatment of Nasopharyngeal Carcinoma

Clinical Study on the Safety and Efficacy of EBV CAR-T /TCR-T Cells in the Treatment of Recurrent / Refractory EBV Positive Nasopharyngeal Carcinoma

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Each subject was observed for at least 4 weeks after cell reinfusion (DLT observation period) . A minimum of three participants should be included in each dose group, and two or more participants should not be included in each dose group at the same time, each subject should not be enrolled until the first 1 subject did not experience a grade 3 or higher adverse event (CTCAE5.0) related to the study drug during the DLT observation period. Three or six subjects were enrolled in each dose group, depending on the occurrence of DLT. If three subjects in one dose group did not experience DLT, three subjects were enrolled in the next higher dose group; if one of three subjects experienced DLT, three more subjects were enrolled in the dose group; Expanded to 6 subjects; if only 1 of the 6 subjects after amplification produced a DLT, then 3 subjects were enrolled into the next higher dose; If a DLT occurred in ≥2 of the 6 subjects after amplification, then the dose was specified to be higher than the MTD (MTD defined as the highest dose at which a DLT occurred in ≤1/6 subjects) , new subjects were included in the previous lower dose (tolerated dose) group until the lower dose group reached 6 subjects. If DLT occurred in ≤1/6 of the subjects, the lower dose group was defined as MTD or the best effective dose. A total of six subjects received the maximum tolerated dose. In the course of the study, the researcher can combine the safety and preliminary efficacy data of the enrolled subjects, and take the safety of the subjects and the maximum benefit of the disease as the premise, study treatment was performed at the maximum tolerated dose or other doses determined by the investigator.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-12-28
• Primary completion: 2027-10-01
• Completion: 2030-10-01
• First posted: 2022-10-20
• Last updated: 2026-04-02

Locations

1 site across 1 country: China