drugset / Trial / NCT05020119
Neoantigen-expanded Autologous Immune Cell Therapy
RandomizedSequentialOpen-labelTreatment
Summary
The investigators aim to investigate the patient's tumor neoantigen to generate "personalized cancer vaccine" and then to expand autologous dendritic cells-cytokine-induced killer cells (DC-CIK). The autologous DC-CIK will be cultured in vitro and re-infused into patients.
Timeline
- Start
- 2021-04-09
- Primary completion
- 2022-06-30
- Completion
- 2023-06-30
Publications
- Background Zacharakis N, Chinnasamy H, Black M, Xu H, Lu YC, Zheng Z, Pasetto A, Langhan M, Shelton T, Prickett T, Gartner J, Jia L, Trebska-McGowan K, Somerville RP, Robbins PF, Rosenberg SA, Goff SL, Feldman SA. Immune recognition of somatic mutations leading to complete durable regression in metastatic breast cancer. Nat Med. 2018 Jun;24(6):724-730. doi: 10.1038/s41591-018-0040-8. Epub 2018 Jun 4.
- Background Chen F, Zou Z, Du J, Su S, Shao J, Meng F, Yang J, Xu Q, Ding N, Yang Y, Liu Q, Wang Q, Sun Z, Zhou S, Du S, Wei J, Liu B. Neoantigen identification strategies enable personalized immunotherapy in refractory solid tumors. J Clin Invest. 2019 Mar 5;129(5):2056-2070. doi: 10.1172/JCI99538. Print 2019 May 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Neoantigen-expanded cell therapy | Cell therapy | 1e+09 cells | — |
| Subject | Neoantigen-expanded cell therapy | Cell therapy | 3e+09 cells | — |
| Subject | Neoantigen-expanded cell therapy | Cell therapy | 9e+09 cells | — |