EBV CAR-T Cells for Nasopharyngeal Carcinoma

• Status: Not yet recruiting
• Trial end date: 2025-12-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Affiliated Hospital of Xuzhou Medical University
• Collaborator: Guangzhou Bioresette Biomedical Technology Co., Ltd.
• Treatments: Cyclophosphamide; Fludarabine

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.