A Prospective Single-Arm Clinical Trial of Radiation Combined With BCMA/CD3 Bispecific Antibody Therapy for Solitary Bone Plasmacytoma With Mild Bone Marrow Infiltration
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
This is a prospective, single-arm, single-center clinical trial designed to evaluate the safety and efficacy of radiation combined with a BCMA/CD3 bispecific antibody (CM336) in patients with solitary bone plasmacytoma (SBP) with mild bone marrow infiltration.
详细描述
This is a prospective, single-arm, single-center clinical trial designed to evaluate the safety and efficacy of radiation combined with a BCMA/CD3 bispecific antibody (CM336) in patients with solitary bone plasmacytoma (SBP) with mild bone marrow infiltration. SBP is a rare plasma cell malignancy with a high risk of progression to multiple myeloma (MM), particularly in patients with minimal bone marrow involvement.
Although radiotherapy is the standard treatment, it is often insufficient to eradicate clonal plasma cells and prevent progression in high-risk patients. CM336, a novel BCMA/CD3 bispecific antibody, has demonstrated promising activity in relapsed/refractory multiple myeloma. In this trial, eligible patients will receive radiotherapy followed by a 12-cycle limited treatment course of CM336, aiming to achieve deep clearance of residual malignant cells and reduce progression risk.
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 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •Histologically confirmed SBP with <10% clonal plasma cells in marrow
- •No prior anti-myeloma therapy. Previous local radiotherapy for SBP is not an exclusion criterion.
- •Meets laboratory and imaging criteria
排除标准
- •Patients who have previously received anti-plasma cell therapy, including melphalan, cyclophosphamide, proteasome inhibitors, immunomodulatory drugs, monoclonal antibodies, bispecific antibodies, or chimeric antigen receptor T-cell (CAR-T) therapy.
- •Any condition that, in the opinion of the investigator, would make the patient unsuitable for participation in this study.
研究组 & 干预措施
BsAbs-treatment group
Patients with solitary bone plasmacytoma (SBP) with mild bone marrow infiltration will receive radiation combined with a BCMA/CD3 bispecific antibody (CM336)
干预措施: BCMA/CD3 bispecific antibody (CM336) (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: From first dose through 28 days after last dose
The primary outcome is to evaluate the safety and tolerability of the combination therapy. This includes the incidence, severity, and type of adverse events (AEs) and serious adverse events (SAEs), graded according to NCI CTCAE v5.0. Particular attention will be paid to cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Safety assessments will include laboratory parameters, vital signs, ECGs, and clinical symptoms.
次要结局
- Progression-Free Survival (PFS)(Up to 5 years)
- Multiple Myeloma Free Survival (MMFS)(Up to 5 years)