Phase I Study of an Oncofetal Antigen ("OFA") Multi-Peptide Immunotherapy ("BBMPI03") in Subjects With Hematologic Cancer
试验速览
- 阶段
- 1 期
- 入组人数
- 4
- 试验地点
- 3
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Open Label Treatment Arm
BB-MPI-03 peptides plus montanide plus sargramostim
干预措施: Sargramostim (Drug)
Open Label Treatment Arm
BB-MPI-03 peptides plus montanide plus sargramostim
干预措施: BB-MPI-03 (Drug)
Open Label Treatment Arm
BB-MPI-03 peptides plus montanide plus sargramostim
干预措施: Montanide (Drug)
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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)
- 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.(12 Months)