LMP2-Specific IL12-secreting TCR-T Cells in the Treatment of EBV-Positive Metastatic/Refractory Nasopharyngeal Carcinoma
![]() |
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04509726 |
Recruitment Status :
Not yet recruiting
First Posted : August 12, 2020
Last Update Posted : August 12, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Nasopharyngeal Carcinoma | Drug: LMBP2-specific TCR-T cell with IL12 auto-secreting element | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Single-Arm Trial of LMP2-Specific TCR-T Cells With IL12 Auto-secreted Element in the Treatment of EBV-Positive Head and Neck Carcinoma Metastatic/Refractory Nasopharyngeal Carcinoma |
Estimated Study Start Date : | September 2020 |
Estimated Primary Completion Date : | August 2021 |
Estimated Study Completion Date : | August 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: EBV TCR-T |
Drug: LMBP2-specific TCR-T cell with IL12 auto-secreting element
Patients were pre-conditioned with chemotherapy and infused with LBMP2-specific TCR-T cells with IL12 auto-secreting element |
- The Maximum Tolerated Dose [ Time Frame: 8 weeks ]Verify the MTD of TCR-T cells for LMP2 antigen for treatment. The first nine patients enrolled in this project will be infused in a dose-climbing approach, with every three patients as a group. The first group of patients returned to 5e+6/kg TCR-T cells, the second group returned to 1e+7/kg TCR-T cells, and the third group returned to 5e+7/kg TCR-T cells. The remaining 11 patients will infused with TCR-Ts in the maximum tolerated dose

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Expected to live longer than 12 weeks
- PS 0-2
- Pathology confirmed as EBV positive NPC, either metastatic or recurrent disease
- Creatinine <2.5mg/dl
- ALT/AST is lower than three times ULN.
- No contraindications of leukocyte collection
- Before entering the trial, women must adopt a reliable method of contraception until 30 days after infusion.
- Understand this trial and have signed an informed consent
Exclusion Criteria:
- Patients with symptomatic brain metastasis
- With other uncontrolled malignant tumors.
- Hepatitis B or Hepatitis C activity period, HIV infected patients
- Any other uncontrolled disease that interferes with the trial
- Patients with severe heart and cerebrovascular diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis and cerebral hemorrhage
- Untreated hypertension or hypertensive patients
- A person with a history of mental illness that is difficult to control
- Researchers do not consider it appropriate to participate in this trial
- Patients who have been using immunosuppressive agents for a long time after organ transplants, except for recent or current inhaled corticosteroids
- Subjects who have been pregnant or nursing, or who plan for pregnancy within 2 months of treatment or after the end of treatment
- An illness affects a person who signs a written consent or complies with a study procedure, or who is unwilling or unable to comply with the research requirements

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): NCT04509726
China, Chongqing | |
Department of Oncology, Xinqiao Hospital | |
ChongQing, Chongqing, China, 400037 |
Responsible Party: | Qingzhu Jia, M.D., Doctor, Xinqiao Hospital of Chongqing |
ClinicalTrials.gov Identifier: | NCT04509726 |
Other Study ID Numbers: |
XQDC20200801 |
First Posted: | August 12, 2020 Key Record Dates |
Last Update Posted: | August 12, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |