drugset / Trial / NCT03185429
TSA-DC Vaccine in Treating Patients With Gastrointestinal Solid Tumor
NaSingle-groupOpen-labelTreatment
Summary
The goal of this study is to learn about the safety and tolerance of autologous TSA-DC cell and evaluate the efficacy and feasibility of the cell therapy compared to the patients' past standard regimen. 20 gastrointestinal solid tumors subjects failed from at least one systemic therapy will be enrolled into the trial and receive a succession of treatment of TSA-DC vaccine.
Timeline
- Start
- 2017-12
- Primary completion
- 2018-12
- Completion
- 2019-06
Publications
- Background Chiang CL, Kandalaft LE, Tanyi J, Hagemann AR, Motz GT, Svoronos N, Montone K, Mantia-Smaldone GM, Smith L, Nisenbaum HL, Levine BL, Kalos M, Czerniecki BJ, Torigian DA, Powell DJ Jr, Mick R, Coukos G. A dendritic cell vaccine pulsed with autologous hypochlorous acid-oxidized ovarian cancer lysate primes effective broad antitumor immunity: from bench to bedside. Clin Cancer Res. 2013 Sep 1;19(17):4801-15. doi: 10.1158/1078-0432.CCR-13-1185. Epub 2013 Jul 9.
- Background Schuler PJ, Harasymczuk M, Visus C, Deleo A, Trivedi S, Lei Y, Argiris A, Gooding W, Butterfield LH, Whiteside TL, Ferris RL. Phase I dendritic cell p53 peptide vaccine for head and neck cancer. Clin Cancer Res. 2014 May 1;20(9):2433-44. doi: 10.1158/1078-0432.CCR-13-2617. Epub 2014 Feb 28.
- Background Carreno BM, Magrini V, Becker-Hapak M, Kaabinejadian S, Hundal J, Petti AA, Ly A, Lie WR, Hildebrand WH, Mardis ER, Linette GP. Cancer immunotherapy. A dendritic cell vaccine increases the breadth and diversity of melanoma neoantigen-specific T cells. Science. 2015 May 15;348(6236):803-8. doi: 10.1126/science.aaa3828. Epub 2015 Apr 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tumor Specific Antigen-loaded Dendritic Cells | Cell therapy | 5e+06 cells | Subcutaneous |
| Subject | Tumor Specific Antigen-loaded Dendritic Cells | Cell therapy | 1e+07 cells | Subcutaneous |
| Background | Cyclophosphamide | Other / unclassified | 300 mg/m2 | Intravenous |