Actively Recruiting
Safety and Efficacy of Anti-EBV Autologous TCR-T Cell Injection in Relapsed/Refractory EBV-Positive Lymphoma
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2025-12-02
24
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of Anti-EBV Autologous TCR-T Cell Injection in Relapsed/Refractory EBV-Positive Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years, male or female
- HLA genotype at locus A must be 11:01
- Histologically or cytologically confirmed EBV-positive lymphoma with peripheral blood EBV viral load >10^3 copies/mL
- Disease type includes NK/T-cell lymphoma, Peripheral T-cell lymphoma, or other related types
- Relapsed disease defined as new lesions after complete remission
- Refractory disease defined by lack of response after specified therapy cycles or progressive disease
- Prior therapy: at least one systemic therapy line for relapsed/refractory PTCL or NK/TCL; asparaginase-containing regimen for NK/TCL; radiotherapy for stage I/II nasal NK/TCL
- At least one measurable lesion by imaging or bone marrow biopsy
- Adequate organ function including blood counts, liver enzymes, kidney function, heart function, and coagulation parameters
- Expected survival greater than 3 months
- ECOG performance status less than 3
- Women of childbearing potential must have a negative pregnancy test and agree to effective contraception during and 4 months after treatment
- Willing to participate, sign consent, comply with protocol, and have peripheral venous access for lymphocyte collection
You will not qualify if you...
- History of other malignancies except certain skin cancers, superficial bladder cancer, carcinoma in situ of cervix or gastrointestinal mucosa, or other investigator-approved cancers with no recurrence in 5 years
- Less than 4 weeks since last anti-cancer therapy or less than 2 weeks since palliative radiotherapy
- Pregnant or breastfeeding women
- Severe medical conditions such as intracranial hypertension, impaired consciousness, respiratory failure, or disseminated intravascular coagulation
- Severe organ dysfunction including NYHA class IV heart failure, Child-Pugh class C liver disease, creatinine clearance <60 mL/min, or oxygen saturation below 92%
- Active infections or positive screening for hepatitis B, hepatitis C, HIV, syphilis, active or history of tuberculosis, or severe infections requiring systemic treatment
- Active central nervous system disease requiring urgent intervention or high-dose immunosuppressive therapy
- Current or recent systemic corticosteroid therapy requiring long-term use, except inhaled or topical
- Graft-versus-host disease grade 2 or higher or current immunosuppressive treatment
- History of severe allergic reactions to study drugs or tocilizumab
- Any condition making the participant unsuitable for the study in the investigator's opinion
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, China
Actively Recruiting
Research Team
X
Xianmin Song, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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