drugset / Trial / NCT01065441
Experimental Therapeutic Cancer Vaccine Created In-situ in Patients With Stage II-Stage IV Cancer
NaSingle-groupOpen-labelTreatment
Summary
A Phase I/II study of an in-situ therapeutic cancer vaccine. Vaccines contain a source of antigen and and adjuvant. In this study the source of tumor antigen comes from the killing of a selected tumor by cryoablation (killing using extreme cold) and the adjuvant is intentionally mis-matched immune cells (AlloStim-TM) engineered to produce inflammatory cytokines.
Timeline
- Start
- 2010-12
- Primary completion
- 2012-12
- Completion
- 2013-07
Publications
- Background Har-Noy M, Zeira M, Weiss L, Fingerut E, Or R, Slavin S. Allogeneic CD3/CD28 cross-linked Th1 memory cells provide potent adjuvant effects for active immunotherapy of leukemia/lymphoma. Leuk Res. 2009 Apr;33(4):525-38. doi: 10.1016/j.leukres.2008.08.017. Epub 2008 Oct 1.
- Background Har-Noy M, Zeira M, Weiss L, Slavin S. Completely mismatched allogeneic CD3/CD28 cross-linked Th1 memory cells elicit anti-leukemia effects in unconditioned hosts without GVHD toxicity. Leuk Res. 2008 Dec;32(12):1903-13. doi: 10.1016/j.leukres.2008.05.007. Epub 2008 Jun 18.
- Background Har-Noy M, Slavin S. The anti-tumor effect of allogeneic bone marrow/stem cell transplant without graft vs. host disease toxicity and without a matched donor requirement? Med Hypotheses. 2008;70(6):1186-92. doi: 10.1016/j.mehy.2007.10.008. Epub 2007 Dec 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AlloStim | Cell therapy | 1e+07 cells | Other |
| Subject | AlloStim | Cell therapy | 4e+07 cells | Other |
| Subject | AlloStim | Cell therapy | 5e+07 cells | Other |
| Subject | AlloStim | Cell therapy | 6e+07 cells | Other |
| Subject | AlloStim | Cell therapy | 1e+08 cells | Other |
| Subject | AlloStim | Cell therapy | 1e+09 cells | Other |