Single-Arm Trial of EBV Specific Cytokine Secreting TCR-T Cells in the Treatment of EBV-Positive Head and Neck Carcinoma Metastatic/Refractory Nasopharyngeal Carcinoma

Who is this study for? Patients with EBV-positive head and neck carcinoma metastatic/refractory nasopharyngeal carcinoma
What treatments are being studied? LMBP2-specific TCR-T cell+IL12 auto-secreting element
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

Epstein-Barr virus (EBV) infections is known to be a high-risk factor to induce cervical cancers. To date, EBV-related nasopharyngeal carcinoma (NPC) is still a major concern in east Asia, especially in China. Concurrent therapies for NPC have limited response rate and high chance of relapse. However, EBV-induced cancers provided an ideal target for T cell-based immunotherapy due to the non-self origins. Engineered T cells bearing a TCR (TCR-T) that can specifically recognize the presented EBV-epitope become a viable approach to treat this type of cancer. Though engineered T therapies have been well-recognized in hematological cancers, solid cancer treatment has been a major hurdle due to the immune-suppressive tumor microenvironment. Cytokine seemed to represent the ideal candidate for tumor immunotherapy, due to its ability to activate both innate (NK cells) and adaptive immunities. therefore, TCR-T cells armed with a cytokine -secretion element could further enhance the efficacy of TCR-T in solid cancers.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Department of Oncology, Xinqiao Hospital
RECRUITING
Chongqing
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2024-12
Participants
Target number of participants: 20
Treatments
Experimental: EBV TCR-T
Related Therapeutic Areas
Sponsors
Leads: Xinqiao Hospital of Chongqing
Collaborators: TCRCure Biopharma Ltd.

This content was sourced from clinicaltrials.gov