To Investigate the Safety and Preliminary Efficacy of EBV CAR-T Cells in the Treatment of Relapsed/Refractory EBV-positive Nasopharyngeal Carcinoma

Status: Recruiting
Location: See location...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

The aim of this study is to investigate the safety and preliminary efficacy of EBV CAR-T cells in the treatment of relapsed/refractory NPC

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 1)Voluntarily sign written informed consent;

• 2)Age ≥18, ≤75 years old, male and female;

• 3 )Estimated survival ≥ 3 months;

• 4\) ECOG physical fitness score was 0-2;

• 5\) EBV positive nasopharyngeal carcinoma was diagnosed;

• 6\) Positive target detection;

• 7\) At least one measurable lesion according to RECIST V1.1 solid tumor evaluation criteria;

• 8\) Patients with recurrent/metastatic nasopharyngeal carcinoma who had previously failed second-line or higher systemic therapy;

• 9\) Monopheresis or venous blood collection venous access can be established, and there are no other contraindications for blood cell separation;

• 10\) Full organ and bone marrow function,

• 11\) Toxicity and side effects left by previous anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, etc.) ≤ grade 1 (CTCAE 5.0);

• 12\) Fertile subjects (male or female) must use effective medical contraception during the study period and for 6 months after the end of administration. In female subjects of reproductive age, a negative pregnancy test should be performed within 72 h prior to the first dose.

Locations
Other Locations
China
The Affiliated Hospital of Xuzhou Medical University
RECRUITING
Xuzhou
Time Frame
Start Date: 2022-01-18
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 24
Treatments
Experimental: CAR-T Cell Injection
A total of 24 patients with recurrent or refractory NPC received a single intravenous infusion of CAR-T cells at doses of 3.0 × 10\^6cells/kg, 9.0 × 10\^6cells/kg, and 1.5 × 10\^7cells/kg, respectively, and were enrolled according to the conventional 3+3 dose escalation.
Related Therapeutic Areas
Sponsors
Collaborators: Guangzhou Bioresette Biomedical Technology Co., Ltd.
Leads: The Affiliated Hospital of Xuzhou Medical University

This content was sourced from clinicaltrials.gov

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