Using EBV CAR-T cells to treat nasopharyngeal carcinoma

To Investigate the Safety and Preliminary Efficacy of EBV CAR-T Cells in the Treatment of Relapsed/Refractory EBV-positive Nasopharyngeal Carcinoma

This study is testing if a new type of immune cell treatment called EBV CAR-T cells can safely help people with hard-to-treat nasopharyngeal cancer.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Affiliated Hospital of Xuzhou Medical University (Academic / other)
• Drugs / interventions: CAR T, chimeric antigen receptor, chemotherapy, immunotherapy, CAR-T
• Locations: 1 site (Xuzhou, Jiangsu)
• Trial ID: NCT05654077 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and preliminary efficacy of EBV CAR-T cells in patients with relapsed or refractory nasopharyngeal carcinoma. It employs a single-arm, open-label, dose-escalation design to determine the maximum tolerated dose of CAR-T cells, with three escalating dose groups. Patients will receive CAR-T cell injections along with fludarabine and cyclophosphamide, followed by a monitoring period of at least four weeks post-infusion to assess safety and effectiveness.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with EBV positive nasopharyngeal carcinoma who have failed previous systemic therapies.

Not a fit: Patients with nasopharyngeal carcinoma who are not EBV positive or have not undergone prior systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients with difficult-to-treat nasopharyngeal carcinoma.

How similar studies have performed: Other studies using CAR-T cell therapy for various cancers have shown promising results, suggesting potential success for this approach in nasopharyngeal carcinoma.

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.

Where this trial is running

Xuzhou, Jiangsu

• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (Recruiting)

Conditions Nasopharyngeal Carcinoma; CAR-T; nasopharyngeal carcinoma; Recurrent/refractory nasopharyngeal carcinoma