drugset / Trial / NCT02882659
Dendritic Killer Cell-based Immunotherapy for Solid Tumors
Phase 1
Unknown
18 enrolled
FullHope Biomedical Co., Ltd.
Taipei Veterans General Hospital, Taiwan · collab
NaSingle-groupOpen-labelTreatment
Summary
The primary objective of this study is to evaluate the safety of autologous dendritic killer cell (DKC) in patients with metastatic solid tumor and to evaluate the maximum tolerated dose (MTD) of DKC. The primary endpoint of safety evaluation includes physical examination, assessment of vital sign, laboratory test, concomitant medication, and adverse event (AE). The secondary endpoints regarding efficacy includes the generation of tumor specific immune response by detecting CD3+ CD8+ CD69+ IFN-gamma+ T cells, and the improvement of quality of life
Timeline
- Start
- 2014-08
- Primary completion
- 2016-01
- Completion
- 2017-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dendritic Killer Cell (DKC) | Cell therapy | 5e+06 cells | — |
| Subject | Dendritic Killer Cell (DKC) | Cell therapy | 1e+07 cells | — |
| Subject | Dendritic Killer Cell (DKC) | Cell therapy | 5e+07 cells | — |