811MO - An exploratory study to assess the safety, immunogenicity, and preliminary anti-tumor activity of the EBV mRNA vaccine (WGc-043 injection) in patients with NK/T cell lymphoma

Background

NK/T cell lymphoma (NKTCL) is a rare and aggressive disease that is often associated with Epstein-Barr virus (EBV) infection and requires novel therapeutic strategies. WGc-043, a therapeutic mRNA vaccine, shows promise against EBV-positive cancers and may provide therapeutic benefit to NKTCL patients by targeting EBV-driven oncogenesis. This study evaluates the safety, immunogenicity, and preliminary antitumor activity of WGc-043 in patients with NKTCL in an IIT.

Methods

This single-center, open-label, exploratory study enrolled 7 patients with EBV-positive relapsed or refractory NKTCL. The primary inclusion criteria were patients with an ECOG of 0-2 who have failed standard therapy. WGc-043 was administered intramuscularly, including 5 doses of base immunization followed by optional personalized treatment. The base immunization was given at week 1, 2, 3, 4 and 8. The primary endpoint is safety. Secondary endpoints include immunogenicity, ORR and DCR. The exploratory analysis focuses on immune biomarkers predictive of therapeutic response.

Results

WGc-043 demonstrated a favorable safety and efficacy profile in patients with NKTCL. It was well tolerated with only grade 1 or 2 adverse events. The most common adverse events were injection site reactions (57.1%) and fever (42.9%), which were transient and resolved without sequelae. Importantly, WGc-043 showed good efficacy, with 3 patients achieving PR and 1 maintaining SD, resulting in an ORR of 42.86% and a DCR of 57.14%. This suggests a potential clinical benefit of using WGc-043 as part of the therapy in this challenging malignancy. Table: 811MO

*NOTE: Definitely related, probably related, and possibly related were classified as treatment-related adverse events. Possibly unrelated and definitely unrelated were classified as treatment unrelated. Data are n (%). No grade 3-5 treatment-related adverse events were reported. Participants could report more than one adverse event.

Conclusions

WGc-043 is well tolerated with a safety profile that reflects its potential for favorable patient outcomes. The observed efficacy in the NKTCL cohort suggests a promising clinical benefit. Further research is needed to confirm these findings and to explore the full potential of the vaccine in larger studies.

Clinical trial identification

NCT05714748.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

WestGene Biopharma Co., Ltd.

Disclosure

H. Huang, X. Li, H. Zheng, J. Chen: Financial Interests, Personal, Full or part-time Employment: WestGene Biopharma Co., Ltd. Y. Wei: Financial Interests, Personal, Ownership Interest, Co-founder & Chairman: WestGene Biopharma Co., Ltd. X. Song: Financial Interests, Personal, Ownership Interest, Co-founder & CEO: WestGene Biopharma. All other authors have declared no conflicts of interest.