Clinical trial · Interventional
EBV CAR-T Cells for Nasopharyngeal Carcinoma
To Investigate the Safety and Preliminary Efficacy of EBV CAR-T Cells in the Treatment of Relapsed/Refractory EBV-positive Nasopharyngeal Carcinoma
NCT05654077CI-TRIAL-00062760unknownEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to investigate the safety and preliminary efficacy of EBV CAR-T cells in the treatment of relapsed/refractory NPC
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAR-T Cell Injection | Biological | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAR-T Cell Injection
- description
- A total of 24 patients with recurrent or refractory NPC received a single intravenous infusion of CAR-T cells at doses of 3.0 × 10\^6cells/kg, 9.0 × 10\^6cells/kg, and 1.5 × 10\^7cells/kg, respectively, and were enrolled according to the conventional "3+3" dose escalation.
- interventionNames
- Biological: CAR-T Cell Injection
- Drug: Fludarabine
- Drug: cyclophosphamide
Primary outcomes (1)
- measure
- Dose-limiting toxicity(DLT)
- timeFrame
- From day 0 to day 28
- description
- Adverse events related to cell therapy were observed on 28 days after CAR-T cell injection , as specified in the protocol
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 1)Voluntarily sign written informed consent; * 2)Age ≥18, ≤75 years old, male and female; * 3 )Estimated survival ≥ 3 months; * 4\) ECOG physical fitness score was 0-2; * 5\) EBV positive nasopharyngeal carcinoma was diagnosed; * 6\) Positive target detection; * 7\) At least one measurable lesion according to RECIST V1.1 solid tumor evaluation criteria; * 8\) Patients with recurrent/metastatic nasopharyngeal carcinoma who had previously failed second-line or higher systemic therapy; * 9\) Monopheresis or venous blood collection venous access can be established, and there are no other contraindications for blood cell separation; * 10\) Full organ and bone marrow function, * 11\) Toxicity and side effects left by previous anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, etc.) ≤ grade 1 (CTCAE 5.0); * 12\) Fertile subjects (male or female) must use effective medical contraception during the study period and for 6 months after the end of administration. In female subjects of reproductive age, a negative pregnancy test should be performed within 72 h prior to the first dose. Exclusion Criteria: * 1\) There are active CNS metastases (except those stabilized by treatment); * 2)HIV positive, HBsAg positive, HBV DNA copy number positive (quantitative test ≥1000cps/ mL), HCV antibody positive and HCV RNA positive; * 3\) Those with mental or psychological diseases who cannot cooperate with treatment and efficacy evaluation; * 4\) subjects with severe autoimmune diseases and long-term use of immunosuppressants; * 5\) Within 14 days prior to enrollment, there were active or uncontrollable infections requiring systemic treatment; * 6\) Any unstable systemic disease * 7\) Complicated with lung, brain, kidney and other important organ dysfunction; * 8\) Subjects have undergone major surgery or trauma in the 4 weeks prior to receiving cell therapy, or are expected to undergo major surgery during the study period; * 9\) Subjects received their last radiotherapy or anti-tumor therapy (chemotherapy, targeted therapy, or immunotherapy) within 4 weeks prior to receiving cell therapy; * 10\) The subject currently has or has had other malignancies that cannot be cured within 3 years, except cervical carcinoma in situ or basal cell carcinoma of the skin, and other malignancies with disease-free survival of more than 5 years; * 11\) T cells modified with chimeric antigen receptor (CAR T, TCR-T) within six months; * 12\) Combined graft versus host disease (GVHD); * 13\) Subjects who were receiving systemic steroids prior to screening and determined by the investigator to require long-term systemic steroid use during treatment (other than inhalation or topical use); And subjects who were treated with systemic steroids (except for inhalation or topical use) within 72 h prior to cell infusion; * 14\) A history of severe allergies or allergies; * 15\) Subjects requiring anticoagulant therapy; * 16\) Women who are pregnant or breast-feeding, or have a pregnancy plan within six months (for both men and women); * 17\) Researchers believe that there are other reasons not to include patients in the treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.