RecruitingEarly Phase 1NCT05587543

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

Sponsor

Fudan University

Enrollment

24 participants

Start Date

Dec 28, 2022

Study Type

INTERVENTIONAL

Conditions

Nasopharyngeal Carcinoma

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of immune cell therapy — called CAR-T or TCR-T cell therapy — for people with a specific type of throat cancer (nasopharyngeal carcinoma) that is linked to a virus called EBV. The therapy uses your own immune cells, which are modified in a lab to better attack the cancer. **You may be eligible if...** - You are 18 to 75 years old - You have EBV-positive nasopharyngeal carcinoma confirmed by lab testing - Your cancer has come back or spread after at least two prior rounds of treatment - You have at least one measurable tumor on imaging - You are in reasonably good overall health (able to care for yourself with some help if needed) **You may NOT be eligible if...** - You have active brain metastases that are not stable - You have HIV, active hepatitis B, or active hepatitis C - You have a severe autoimmune disease or take long-term immunosuppressants - You received another CAR-T therapy within the last 6 months - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALPK Blood Collection

All subjects were subjected to PK blood sampling as prescribed by the protocol.

DRUGCAR

Target A positive subjects will receive CAR-T cell therapy.

DRUGTCR

Target A negative, Target B positive and Target C positive subjects will receive TCR-T cell therapy.

Locations(1)

Fudan University

Shanghai, China

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NCT05587543

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