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Phase I Trial of LMP2 Antigen-specific TCR T-cell Therapy for Recurrent and Metastatic NPC Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03925896
Recruitment Status : Unknown
Verified September 2019 by Hai-Qiang Mai,MD,PhD, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : April 24, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Hai-Qiang Mai,MD,PhD, Sun Yat-sen University

Study Description
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Brief Summary:
In this study, a single-arm, open-labeled clinical trial will be performed to determine the safety and efficacy of EBV TCR-T cells in the treatment of recurrent/metastatic nasopharyngeal carcinoma with positive EBV infection in the Chinese population.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: LMP2 Antigen-specific TCR T cells Phase 1

Detailed Description:
All enrolled subjects will be infused with EBV TCR-T cells. The project which enrolls 27 patients, according to the patient's HLA subtypes will be divided into HLA-A2, HLA-A11, HLA-A24 three groups, 9 patients in each group. Using a dose climbing method, each group will be divided into three dose subgroups. In the first dose subgroup, 5×106/kg TCR-T cells will be returned, and in the second dose subgroup, 1×107/kg TCR-T cells will be returned. The third dose subgroup 5 x 107/kg TCR-T cells will be returned.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LMP2 Antigen-specific High-affinity T Cell Receptor (TCR)-Transduced Autologous T-cell Therapy for Recurrent and Metastatic Nasopharyngeal Carcinoma, an Open-label, Single-center, Phase I Clinical Trial
Actual Study Start Date : August 7, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: LMP2 Antigen-specific TCR T cells
All enrolled subjects will be infused with EBV TCR-T cells. The project which enrolls 27 patients, according to the patient's HLA subtypes will be divided into HLA-A2, HLA-A11, HLA-A24 three groups, 9 patients in each group. Using a dose climbing method, each group will be divided into three dose subgroups. In the first dose subgroup, 5×106/kg TCR-T cells will be returned, and in the second dose subgroup, 1×107/kg TCR-T cells will be returned. The third dose subgroup 5 x 107/kg TCR-T cells will be returned.
 Drug: LMP2 Antigen-specific TCR T cells
All enrolled subjects will be infused with EBV TCR-T cells. The project which enrolls 27 patients, according to the patient's HLA subtypes will be divided into HLA-A2, HLA-A11, HLA-A24 three groups, 9 patients in each group. Using a dose climbing method, each group will be divided into three dose subgroups. In the first dose subgroup, 5×106/kg TCR-T cells will be returned, and in the second dose subgroup, 1×107/kg TCR-T cells will be returned. The third dose subgroup 5 x 107/kg TCR-T cells will be returned.
Other Name: EBV specific TCR-T cells


Outcome Measures
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Primary Outcome Measures :
  1. To Determine the Maximum Tolerated Dose of TCR T-cell Therapy [ Time Frame: 2 years ]
    Verify the MTD of LMP2 Antigen-specific TCR T-cell Therapy


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Patients with nasopharyngeal carcinoma diagnosed by pathology and EBV infection (EBERs positive ) ; 2.18-70 years old; 3.MHC-I is HLA-A2, HLA-A11 or HLA-A24 subtype; 4. Progression after second-line platinum-containing chemotherapy regimen, recurrent/metastatic nasopharyngeal carcinoma patients who are inoperable and non-radiable; 5. Based on the Response Evaluation Criteria in Solid Tumors version (RECIST 1.1), there are ≥ 1 measurable target lesions; 6. Expected survival time is more than 12 weeks; 7. ECOG score 0-2 points; 8. Patients with good bone marrow, kidney, liver, and heart, and lung function 9. Can establish the venous access required for the collection, no contraindications for white blood cell collection; 10. Male and female patients of the appropriate age must adopt a reliable method of contraception; 11. Those who understand the trial and have signed an informed consent form.

Exclusion Criteria:

  1. Patients with symptomatic brain metastasis;
  2. Other malignant tumors other than nasopharyngeal carcinoma within 5 years prior to enrollment, in addition to appropriate treatment of cervical carcinoma in situ, cutaneous basal or squamous cell carcinoma, localized prostate cancer or ductal carcinoma in situ after radical surgery ;
  3. Hepatitis B or hepatitis C active period, HIV-infected;
  4. Any other uncontrolled active disease that impedes participation in the trial;
  5. Patients with severe heart and cerebrovascular diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, and cerebral hemorrhage;
  6. 2-3 grade hypertension or patients with poorly controlled hypertension;
  7. Those with a history of mental illness that are difficult to control;
  8. The investigator believes that it is not appropriate to participate in the trial;
  9. Those who have been using immunosuppressive agents for a long time after organ transplantation, except for recent or current inhaled corticosteroids;
  10. In the opinion of the investigator, the presence of medical history or mental state history or laboratory abnormalities may increase the risk associated with participating in the study or study drug administration, or may interfere with the interpretation of the results;
  11. Screening indicates that the target cell transfection rate is less than 30%, or the T cell expansion is insufficient (less than 5 times) under CD3/CD28 stimulation conditions;
  12. Unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events occurred 30 days or 30 days prior to grouping. If receiving anticoagulant therapy, the subject's therapeutic dose must be stable before grouping;
  13. A subject who is pregnant or breastfeeding, or who is planning a pregnancy during or after 2 months of treatment;
  14. Subjects who are women of childbearing age who are reluctant to receive high-efficiency contraception (according to institutional standards) during treatment and at least 2 months after the end of treatment. Female subjects of childbearing age are required to provide a negative result of a serum or urine pregnancy test within 48 hours prior to treatment;
  15. There are active or uncontrollable infections requiring systemic treatment within 14 or 14 days prior to grouping;
  16. Subjects who are unwilling or unable to comply with the research requirements.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03925896


Contacts
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Contact: Hai Qiang Mai, MD.PHD 020-87343380 maihq@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen Universitty Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Hai-Qiang Mai, MD,PhD    +862087343643    maihq@sysucc.org.cn   
Principal Investigator: Hai-Qiang Mai, MD,PhD         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Study Chair: Hai Qiang Mai, MD,PhD Sun Yat-sen University
More Information
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Publications:

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Responsible Party: Hai-Qiang Mai,MD,PhD, MD,PhD, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03925896    
Other Study ID Numbers: B2019-021
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hai-Qiang Mai,MD,PhD, Sun Yat-sen University:
EBV TCR-T cells
recurrent
metastatic
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal 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