Clinical Study on the EBV CAR-T /TCR-T Cells in the Treatment of Nasopharyngeal Carcinoma

NCT05587543 | Recruiting Early Phase 1

• 1 other identifier: 2207257-17
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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. The EBV CAR-T-treated group received three progressively increasing dose levels (3.0 × 106 cells/kg, 9.0 × 106 cells/kg, 1.5 × 107 cells/kg) of EBV CAR-T-cell therapy; The EBV TCR-T-cell group received three progressively increasing doses (5.0 × 106 cells/kg, 1.5 × 107 cells/kg, 3.0 × 107 cells/kg) of EBV TCR-T-cell therapy.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (3)

• Dose Limiting Toxicities

  Analysis based on clinical trial data of subjects

  one year

• MTD or the best effective dose

  Analysis based on clinical trial data of subjects

  one year

• Incidence of AE、SAE、AESI

  Analysis based on clinical trial data of subjects

  one year

Secondary Outcomes (6)

• PK parameter：Cmax

  one year

• PK parameter：Tmax

  one year

• ORR

  one year

• DCR

  one year

• DOR

  one year

Study Arms (2)

CAR-T

EXPERIMENTAL

Target A positivity was assigned to CAR-T cell therapy.

Behavioral: PK Blood Collection; Drug: CAR

TCR-T

EXPERIMENTAL

Target A negative, Target B positive and Target C positive were assigned to TCR-T cell treatment group.

Behavioral: PK Blood Collection; Drug: TCR

Interventions

PK Blood Collection BEHAVIORAL

All subjects were subjected to PK blood sampling as prescribed by the protocol.

CAR-T; TCR-T

CAR DRUG

Target A positive subjects will receive CAR-T cell therapy.

Also known as: CAR-T cell therapy

CAR-T

TCR DRUG

Target A negative, Target B positive and Target C positive subjects will receive TCR-T cell therapy.

Also known as: TCR -T cell therapy

TCR-T

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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) .
• 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.

You may not qualify 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;
• 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;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University

Shanghai, China

RECRUITING

Related Publications (20)

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MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Automobiles; Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Motor Vehicles; Transportation; Technology, Industry, and Agriculture; Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Dongmei Ji, Doctorate

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongmei Ji, Doctorate

CONTACT

13564183928; jidongmei2000@hotmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Doctor

Model Details: CAR-T、TCR-T

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 20, 2022
• Study Start: December 28, 2022
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2030
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)