ISRCTN26168155进行中（未招募）1 期
An open-label, multicenter, Phase Ib trial evaluating the safety, pharmacokinetics, and activity of subcutaneous cevostamab (BFCR4350A) in patients with relapsed or refractory multiple myeloma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 170
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age =18 years at time of signing Informed Consent Form
- •2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •3. Life expectancy of at least 12 weeks
- •4. Participants with a diagnosis of R/R MM for which no established therapy for multiple myeloma (MM) is appropriate and available, or intolerance to those established therapies
- •5. Agreement to provide bone marrow biopsy and aspirate samples
- •6. Adverse events from prior anti-cancer therapy resolved to Grade less than or equal to (=) 1, except any grade alopecia and peripheral sensory or motor neuropathy which must have resolved to Grade = 2
- •7. Measurable disease defined by laboratory test results
排除标准
- •Current participant exclusion criteria as of 06/06/2024:
- •1. Prior treatment with cevostamab or another agent targeting fragment crystallizable receptor-like 5 (FcRH5)
- •2. Inability to comply with protocol-mandated hospitalization and activities restrictions
- •3. Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the last dose of cevostamab or within 3 months after the last dose of tocilizumab (if applicable)
- •4. Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate as anti-cancer therapy within 4 weeks prior to first study treatment, except for the use of non-myeloma therapy
- •5. Prior treatment with systemic checkpoint inhibitors, including, but not limited to anti-CTLA4, anti-PD-1, and anti-PD-L1 therapeutic antibodies within 12 weeks or 5 half-lives of the drug, whichever is shorter, prior to first study treatment
- •6. Prior treatment with allogeneic or autologous chimeric antigen receptor (CAR) T-cell therapy within 12 weeks prior to first study treatment
- •7. Known treatment-related, immune-mediated adverse events associated with prior checkpoint inhibitors
- •8. Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
- •9. Treatment with any chemotherapeutic agent or other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first study treatment
- •10. Treatment with radiotherapy within 4 weeks (systemic radiation) or 14 days (focal radiation) prior to first study treatment
- •11. Autologous stem cell transplant (SCT) within 100 days prior to first study treatment
- •12. Prior allogeneic SCT
- •13. Prior solid organ transplantation
- •14. Circulating plasma cell count exceeding 500/microlitres (µL) or 5% of the peripheral blood white cells
- •15. History of autoimmune disease
- •16. History of confirmed progressive multifocal leukoencephalopathy
- •17. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
- •18. Known history of amyloidosis (e.g., positive Congo Red stain or equivalent in tissue biopsy)
- •19. Participants with lesions in proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare
- •20. History of other malignancy within 2 years prior to screening, except those with negligible risk of metastasis or death
- •21. Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, neurodegenerative disease, or CNS involvement by MM
- •22. Significant cardiovascular disease that may limit a participant's ability to adequately respond to a CRS event
- •23. Symptomatic active pulmonary disease or requiring supplemental oxygen
- •24. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antimicrobials where the last dose of IV antimicrobial was given within 14 days prior to first study treatment
- •25. Active symptomatic COVID-19 infection at study enrollment or requiring treatment with IV antiviral where the last dose of IV antiviral treatment was given within 14 days prior to first study treatment. Patients with active COVID-19 infection must have clinical recovery and two negative antigen tests at least 24 hours apart prior to first study treatment
- •26. Positive and
研究者
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