Safety and Efficacy of Anti-EBV Autologous TCR-T Cell Injection in Relapsed/Refractory EBV-Positive Lymphoma

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

This study will test whether anti-EBV autologous TCR-T cell injection is safe and effective for patients with relapsed or refractory EBV-positive lymphoma who have HLA-A11:01. Researchers will look at safety, tolerability, and the maximum tolerated dose or recommended dose for future studies.

The study will also measure how the infused TCR-T cells expand and persist in the body, changes in EBV DNA levels and T-cell subgroups in the blood, and whether the treatment shows early signs of clinical benefit. Researchers will also explore whether the treatment causes an immune response against the infused cells.

Eligibility criteria

Qualifiers

Age 18-70 years, male or female.

HLA genotype at locus A is 11:01.

Histologically or cytologically confirmed EBV-positive lymphoma (tumor tissue must be EBER-positive as confirmed by in situ hybridization [ISH] or fluorescence in situ hybridization [FISH]), with peripheral blood EBV viral load >10³ copies/mL by quantitative real-time PCR.

Definition of relapse: appearance of new lesions at the primary site or other sites after achieving complete remission (CR).

Disqualifiers

Basal cell carcinoma of the skin;

Squamous cell carcinoma of the skin;

Superficial bladder cancer;

Carcinoma in situ of the cervix;

Trial design

Treatments tested in this trial

  • EBV TCR-T

Treatment groups

24 Participants
are divided into 1 treatment group