drugset / Trial / NCT02240537
Phase I Study of an Oncofetal Antigen Multi-Peptide Immunotherapy in Subjects With Hematologic Cancer
NaSingle-groupOpen-labelTreatment
Summary
The study is designed to evaluate safety, immunogenicity, and preliminary anti-tumor activity of a multi-peptide immunotherapy (BB-MPI-03) at three peptide+adjuvant dose levels. The peptides stimulate cytotoxic T-cells targeting oncofetal antigen (OFA). Subjects with AML, MM, sMM, or MDS who are off treatment and with stable disease or better, or who are not eligible for or refuse allogeneic HSCT are to be enrolled. The study will be conducted at 2 to 4 study centers in the US.
Timeline
- Start
- 2015-01
- Primary completion
- 2016-12
- Completion
- 2017-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BB-MPI-03 | Unknown | 0.75 mg | Other |
| Subject | BB-MPI-03 | Unknown | 1.5 mg | Other |
| Subject | BB-MPI-03 | Unknown | 3 mg | Other |
| Background | Montanide | Other / unclassified | — | Other |
| Background | sargramostim | Protein / enzyme biologic | 250 ug | Other |