Actively Recruiting
Clinical Study on the EBV CAR-T /TCR-T Cells in the Treatment of Nasopharyngeal Carcinoma
Led by Fudan University · Updated on 2026-04-02
24
Participants Needed
1
Research Sites
404 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Clinical Study on the EBV CAR-T /TCR-T Cells in the Treatment of Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written informed consent
- Age 18 to 75 years, male or female
- Expected survival of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) physical fitness score of 0 to 2
- EBV-positive nasopharyngeal carcinoma confirmed by in situ hybridization with Ebers (Eber-fish)
- Pathological paraffin section testing within 5 years before signing consent
- At least one measurable lesion according to RECIST v1.1 criteria
- Recurrent or metastatic nasopharyngeal carcinoma with prior failure of second-line or more systemic therapy
- Ability to establish apheresis or venous access with no contraindications to blood cell isolation
- Side effects from previous anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy) lower than grade 1 per CTCAE 5.0
- Fertile subjects must use effective contraception during the study and up to 6 months after administration
- Negative pregnancy test within 72 hours before first dose for women of reproductive age
You will not qualify if you...
- Active central nervous system metastases (except stable after treatment)
- HIV positive, HBsAg positive with HBV DNA >1000 CPS/ml, HCV antibody positive with HCV RNA positive
- Mental or psychological disorders preventing cooperation with treatment and evaluation
- Severe autoimmune disease with long-term immunosuppressant use
- Active or uncontrolled infection requiring systemic therapy within 14 days prior to enrollment
- Any unstable systemic disease
- Dysfunction of important organs such as lung, brain, or kidney
- Major surgery or severe trauma within 4 weeks before cell therapy or expected during study
- Radiation or anti-tumor therapy within 4 weeks before cell therapy
- Other incurable cancers within 3 years except certain skin or cervical cancers
- Chimeric antigen receptor T-cell therapy within 6 months
- Graft-versus-host disease (GVHD)
- Systemic steroid therapy before screening or requiring long-term systemic steroids during treatment (except inhaled or topical)
- Systemic steroid treatment within 72 hours before cell reinfusion (except inhaled or topical)
- Severe allergies or history of allergies
- Requirement for anticoagulant therapy
- Pregnant or lactating women, or planning pregnancy within 6 months
- Other reasons as determined by the investigator for exclusion
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Trial Site Locations
Total: 1 location
1
Fudan University
Shanghai, China
Actively Recruiting
Research Team
D
Dongmei Ji, Doctorate
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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