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New treatment option for Nasopharyngeal Carcinoma
Official title Clinical Study on the EBV CAR-T /TCR-T Cells in the Treatment of Nasopharyngeal Carcinoma
ClinicalTrials.gov ID: NCT05587543
What this study is testing
What is CAR?
CAR is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for nasopharyngeal carcinoma.
Also referred to as CAR-T cell therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study was a single-arm, open-label, "3 + 3" dose-escalation Exploratory research. The patients were divided into two groups: EBV TCR-T-cell Group and EBV CAR-T-cell group.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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) .
You likely can't join if
- 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;
- people 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;
See the full eligibility 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 people -LRB-both male and female) were required to use effective medical contraception. For women of reproductive age, a pregnancy...
- 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;
- people 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.
- people 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)；
- people 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)...
- Severe allergies or a history of allergies;
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.