Phase I Study of an Oncofetal Antigen Multi-Peptide Immunotherapy in Subjects With Hematologic Cancer
- Conditions
- Smoldering Multiple Myeloma (sMM)Acute Myelogenous Leukemia (AML)Multiple Myeloma (MM)Myelodysplastic Syndrome (MDS)
- Interventions
- Registration Number
- NCT02240537
- Lead Sponsor
- Benovus Bio, Inc.
- Brief 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.
- Detailed Description
The current study is a Phase I, open-label, multi-center, dose escalation study designed to evaluate safety, immunogencity, and potential anti-tumor activity of BB-MPI-03 at three peptide plus adjuvant dose levels. Subjects with acute myelogenous leukemia (AML), multiple myeloma (MM), smoldering multiple myeloma (sMM), or myelodysplastic syndrome (MDS) who are off treatment and with stable disease or better or who are not eligible for or refuse allogeneic hematopoietic stem cell transplantation (HSCT) are to be enrolled. The study will be conducted at 2 to 4 study centers in the United States (US).
The study employs a sequential group, open-label, 3+3 dose- escalation design to determine the safety and MTD of BB- MPI-03.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 4
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Open Label Treatment Arm Montanide BB-MPI-03 peptides plus montanide plus sargramostim Open Label Treatment Arm BB-MPI-03 BB-MPI-03 peptides plus montanide plus sargramostim Open Label Treatment Arm Sargramostim BB-MPI-03 peptides plus montanide plus sargramostim
- Primary Outcome Measures
Name Time Method Determine the safety, dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and optimal biologic dose (OBD) of BB-MPI-03 and adjuvants in subjects with hematologic cancers who are off treatment and with stable disease (SD) or better. 6 months treatment, 6 months follow-up The safety and tolerability of BB-MPI-03 in Montanide emulsion preceded by sargramostim will be measured by:
* The proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs), DLTs, and AEs leading to study vaccine discontinuation.
* The proportion of subjects requiring a modification of the study treatment dose or schedule.
* Change from baseline in absolute neutrophil counts (ANC) and platelet counts.
* The proportion of subjects with local injection site reactivity.
* Proportion of subjects experiencing infections or fevers requiring hospitalization and/or intravenous (IV) antibiotics.
- Secondary Outcome Measures
Name Time Method Evaluate any anti-tumor activity of BB-MPI-03 and adjuvants as assessed by disease reduction and lack of disease progression during and after treatment. 12 Months The anti-tumor activity of BB MPI 03 in Montanide emulsion preceded by sargramostim will be measured by:
Time to progression (TTP) Overall response rate at Month 7 Best Overall ResponseDetermine the in vivo cellular immune response profile of BB-MPI-03 and adjuvants in subjects who receive 5 and 6 intradermal (ID) injections over a 6- month period. 12 Months Immunologic responses (change from Baseline) will be assessed by:
* DTH reaction to the peptides, as measured and photographed at 7 months using the "ballpoint pen" method.
* Peptide-specific T-cell proliferation to ELISPOT and tetramer assay.
* Level of OFA expression on tumor cells at Month 7.
* Anti-peptide (anti-OFA) antibodies in the serum. These parameters will be measured at D15, D29, M2, M3, M6, M9, and M12 and compared to pre-treatment Baseline. DTH reaction to the peptides and OFA expression will be measured and recorded at 1 month after the last injection (M7).
Trial Locations
- Locations (3)
University of Chicago
🇺🇸Chicago, Illinois, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Virginia Cancer Specialists
🇺🇸Fairfax, Virginia, United States