drugset / Trial / NCT02030561
NK Cell Infusions With Trastuzumab for Patients With HER2+ Breast and Gastric Cancer
Phase 1/2
Unknown
29 enrolled
National University Hospital, Singapore
National University of Singapore · collab
NaSingle-groupOpen-labelTreatment
Summary
This study will determine the safety and efficacy of expanded activated autologous NK cells administered after Trastuzumab in patients with HER2-positive breast or gastric cancer. It will also provide valuable insights of the role of NK cell infusions in adult solid tumors.
Timeline
- Start
- 2014-01
- Primary completion
- 2017-08
- Completion
- 2018-08
Publications
- Background Beano A, Signorino E, Evangelista A, Brusa D, Mistrangelo M, Polimeni MA, Spadi R, Donadio M, Ciuffreda L, Matera L. Correlation between NK function and response to trastuzumab in metastatic breast cancer patients. J Transl Med. 2008 May 16;6:25. doi: 10.1186/1479-5876-6-25.
- Background Voskens CJ, Watanabe R, Rollins S, Campana D, Hasumi K, Mann DL. Ex-vivo expanded human NK cells express activating receptors that mediate cytotoxicity of allogeneic and autologous cancer cell lines by direct recognition and antibody directed cellular cytotoxicity. J Exp Clin Cancer Res. 2010 Oct 11;29(1):134. doi: 10.1186/1756-9966-29-134.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TROCULEUCEL | Cell therapy | — | — |
| Subject | Trastuzumab | Monoclonal antibody | — | Intravenous |