Phase I Study of an Oncofetal Antigen Multi-Peptide Immunotherapy in Subjects With Hematologic Cancer (BBMPI03)
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|ClinicalTrials.gov Identifier: NCT02240537|
Recruitment Status : Unknown
Verified April 2016 by Benovus Bio, Inc..
Recruitment status was: Active, not recruiting
First Posted : September 15, 2014
Last Update Posted : April 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Acute Myelogenous Leukemia (AML) Multiple Myeloma (MM) Myelodysplastic Syndrome (MDS) Smoldering Multiple Myeloma (sMM)||Drug: Sargramostim Drug: BB-MPI-03 Drug: Montanide||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of an Oncofetal Antigen ("OFA") Multi-Peptide Immunotherapy ("BBMPI03") in Subjects With Hematologic Cancer|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||June 2017|
Experimental: Open Label Treatment Arm
BB-MPI-03 peptides plus montanide plus sargramostim
Drug: Sargramostim (GM-CSF) Other Names: Leukine Sargramostim (250 ug vial) is reconstituted with 0.5 ml of Sterile Water for Injection. Subjects will receive 0.5 ml intradermally (250 µg) near the arm pit or inside of thigh.
Other Name: Leukine
Other Names: Multi-peptide immunotherapy (MPI) is comprised of 3 cytotoxic T-cell epitopes derived from oncofetal antigen. There are 3 dose levels of study vaccine planned to be tested, starting at 0.25 mg each peptide (0.75 mg total peptide dose), then 0.5 mg of each peptide (1.5 mg total) and finally 1 mg each peptide (3 mg total). At the starting dose of 0.75 mg, the BB MPI 03-15 mg vial is used and 100 ul is administered; at the 1.5 mg dose, 200 ul of the BB MPI 03-15 mg vial is used; at the 3 mg dose, 200 ul of the BB MPI 03-30 mg is used.
Other Name: Multi-peptide Immunotherapy
Drug: Montanide Other Names: mineral oil, USP BB-MPI-03 is emulsified with Montanide and administered intradermally (ID) within 1-2 cm of the 2 sargramostim injection sites 1-3 minutes after sargramostim administration.
Subjects and the injection sites are to be monitored for 1 hour after sargramostim and BB-MPI-03 emulsion administration.
Other Name: Emulsion
- 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. [ Time Frame: 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.
- Determine 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. [ Time Frame: 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).
- 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. [ Time Frame: 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 Response
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02240537
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Virginia|
|Virginia Cancer Specialists|
|Fairfax, Virginia, United States, 22031|