Using EBV CAR-T and TCR-T cells to treat nasopharyngeal carcinoma

Clinical Study on the Safety and Efficacy of EBV CAR-T /TCR-T Cells in the Treatment of Recurrent / Refractory EBV Positive Nasopharyngeal Carcinoma

This study is testing two types of specially engineered immune cells to see if they can safely help people with nasopharyngeal carcinoma.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: Chimeric antigen receptor, chemotherapy, radiation, CAR-T
• Locations: 1 site (Shanghai)
• Trial ID: NCT05587543 on ClinicalTrials.gov

What this trial studies

This clinical study investigates the safety and preliminary efficacy of two types of engineered T cells, EBV CAR-T cells and EBV TCR-T cells, in patients with nasopharyngeal carcinoma. Participants are divided into two groups, each receiving progressively increasing doses of their respective T cell therapies. The study employs a dose-escalation design to determine the maximum tolerated dose while monitoring for any dose-limiting toxicities. Each subject is observed for at least four weeks after cell reinfusion to assess treatment effects and safety.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with EBV-positive nasopharyngeal carcinoma who have experienced treatment failure after second-line therapy.

Not a fit: Patients with early-stage nasopharyngeal carcinoma or those who 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 and effective option for patients with recurrent or metastatic nasopharyngeal carcinoma who have not responded to previous therapies.

How similar studies have performed: While the use of CAR-T and TCR-T cell therapies is gaining traction, this specific approach for nasopharyngeal carcinoma is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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.

Where this trial is running

Shanghai

• Fudan University — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Dongmei Ji, Doctorate — Fudan University
• Study coordinator: Dongmei Ji, Doctorate

Conditions Nasopharyngeal Carcinoma