Clinical Study on the EBV CAR-T /TCR-T Cells in the Treatment of 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

Inclusion Criteria:

* Voluntary written informed consent;
* Age ≥18 years old, ≤75 years old, male and female;
* Expected survival ≥3 months;
* The Eastern Cooperative Oncology Group (ECOG) physical fitness score was 0-2;
* Ebv-positive nasopharyngeal carcinoma was diagnosed by in situ hybridization with Ebers (Eber-fish) .
* Pathological Paraffin section testing (within 5 years before signing the informed consent form) ;
* At least one measurable lesion according to RECIST v1.1 criteria for solid tumors;
* Recurrent/metastatic nasopharyngeal carcinoma patients who had previously failed second-line or more systemic therapy;
* An apheresis or venous access can be established and there are no other contraindications to blood cell isolation；
* CTCAE 5.0 was lower than grade 1 in the side effects of previous anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, etc.)
* During the study period and up to 6 months after the end of the administration, fertile subjects -LRB-both male and female) were required to use effective medical contraception. For women of reproductive age, a pregnancy test should be performed within 72 hours before the first dose, and the results were negative.

Exclusion Criteria:

* Active central nervous system metastases (except those that are stable after treatment)；
* HIV positive, HBsAg positive and HBV DNA copy number positive (quantitative detection ≥1000 CPS/ml) , HCV antibody positive and HCV RNA positive;
* Patients with mental or psychological disorders who can not cooperate with the treatment and evaluation of the curative effect;
* Subjects with severe autoimmune disease and long-term use of immunosuppressants;
* Active or uncontrolled infection requiring systemic therapy was present within 14 days prior to enrollment；
* Any unstable systemic disease;
* Complicated with dysfunction of important organs such as lung, brain and kidney.
* Subjects had undergone major surgery or severe trauma within 4 weeks before receiving cell therapy, or were expected to undergo major surgery during the study period.
* Participants received their last dose of radiation or anti-tumor therapy within 4 weeks of receiving the cell therapy.
* Participants had or had had other cancers that were incurable for up to 3 years, except for cervical cancer in situ or skin basal-cell carcinoma, and other cancers that had disease-free survival of more than 5 years.
* Treated with Chimeric antigen receptor t-cell therapy within six months.
* Graft-versus-host disease (GVHD)；
* Subjects who were receiving systemic steroid therapy before screening and who required long-term systemic steroid therapy during treatment as determined by the investigator (with the exception of inhaled or topical use) ; And subjects treated with systemic steroids within 72 hours before cell reinfusion (except for inhalation or topical use) .
* Severe allergies or a history of allergies;
* Subjects requiring anticoagulant therapy;
* Pregnant or lactating women, or a six-month pregnancy plan (for both men and women)；
* Researchers believe there are other reasons not to include people in treatment.

Conditions2

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