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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fudan University
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Dongmei Ji, Doctorate — Fudan University
• Study coordinator: Dongmei Ji, Doctorate
• Email: jidongmei2000@hotmail.com
• Phone: 13564183928

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.