EBV CAR-T Cells for Nasopharyngeal Carcinoma

Launched by THE AFFILIATED HOSPITAL OF XUZHOU MEDICAL UNIVERSITY · Dec 7, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with nasopharyngeal carcinoma (NPC), a type of cancer that starts in the nasopharynx, which is the area behind the nose and above the back of the throat. The trial is testing a special therapy using modified immune cells, known as EBV CAR-T cells, to see if it is safe and effective for people whose cancer has returned or hasn't responded to previous treatments.

Eligible participants are adults aged 18 to 75 years who have been diagnosed with EBV-positive nasopharyngeal carcinoma and have had at least one measurable tumor. They should be in reasonably good health and not have certain serious conditions or recent treatments that could interfere with the study. If someone chooses to participate, they can expect careful monitoring throughout the trial to assess their safety and how well the treatment works. It's an opportunity to explore a potential new treatment option while contributing to important research in cancer care.

Gender

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Eligibility criteria

• 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.