EUCTR2013-001418-13-GR进行中（未招募）1 期
A Phase I Dose Escalation Safety and Pharmacokinetic Study of Multiple Intravenous Administrations of a Humanized Monoclonal Antibody (SAR650984) Against CD38 In Patients with Selected CD38+ Hematological MalignanciesRevised title (protocol amendment 8)A Phase 1/2 Dose Escalation Safety, Pharmacokinetic and Efficacy Study of Multiple Intravenous Administrations of a Humanized Monoclonal Antibody (SAR650984) Against CD38 In Patients with Selected CD38+ Hematological Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 248
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- For dose escalation cohorts, patients with confirmed selected CD38+ hematological malignancies as specified below who have progressed on after standard therapy or for whom there is no effective standard therapy (refractory/relapsed patients). B-cell Non-Hodgkin-lymphoma/leukemia (NHL) patients having at least 1 measurable lesion. Multiple myeloma (MM) patients with measurable M-protein serum and/or 24-hour urine. Acute myeloid leukemia (AML) patients, all types except M3 based on French-American-British (FAB) classification. Acute Lymphoblastic Leukemia (B-cell ALL) patients. Chronic lymphocytic leukemia (CLL) patients.
- •- For expansion cohorts, patients with relapsed/refractory MM with measurable M-protein (serum M-protein of >0.5 g/dL and/or urine M-protein of >200 mg (24- hr urine)) or elevated serum free light chains (FLC) >10 mg/dL with abnormal
- •FLC ratio) AND who meet the protocol defined criteria for standard risk or high risk.
- •- Patients must have a known diagnosis of multiple myeloma with evidence of measurable disease, AND have evidence of disease progression based on
- •International Myeloma Working Group (IMWG) criteria: Serum M-protein =1 g/dL, or urine M-protein =200 mg/24 hours or in the absence of measurable mprotein, serum FLC =10 mg/dL, and abnormal serum immunoglobulin kappa
- •lambda FLC ratio.
- •- Patients must have received at least three prior lines of therapy for MM and must include treatment with an Immunomodulatory drug (IMiD) (for =2 cycles or =2 months of treatment) and a proteasome inhibitor (PI) (for =2 cycles or =2 months of treatment) OR patients whose disease is double refractory to an IMiD and a PI. For patients who have received more than 1 type of IMiD and PI, their disease must be refractory to the most recent one.
- •- Patients must have achieved a minimal response or better to at least one prior line of therapy.
- •- Patients must have received an alkylating agent (=2 cycles or =2 months) either alone or in combination with other MM treatments.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 124
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 124
排除标准
- •- Karnofsky performance status <60
- •- Poor bone marrow reserve
- •- Poor organ function
- •- Known intolerance/hypersensitivity to infused protein products, sucrose or polysorbate 80
- •- Any serious active disease (including clinically significant infection that is chronic, recurrent, or active) or co-morbid condition, which, in the opinion of the investigator, could interfere with the safety, the compliance with the study or with
- •the interpretation of the results
- •- Any severe underlying medical conditions including presence of laboratory abnormalities, which could impair the ability to participate in the study or the interpretation of its results
- •- Patients with multiple myeloma IgM subtype
- •- Previous treatment with any anti-CD38 therapy
- •- Patients with concurrent plasma cell leukemia
- •- Patients with known or suspected amyloidosis
- •- Karnofsky performance status <60
- •- Poor bone marrow reserve
- •- Poor organ function
- •- Known intolerance/hypersensitivity to infused protein products, sucrose or polysorbate 80
- •- Any serious active disease (including clinically significant infection that is chronic, recurrent, or active) or co-morbid condition, which, in the opinion of the investigator, could interfere with the safety, the compliance with the study or with
- •the interpretation of the results
- •- Any severe underlying medical conditions including presence of laboratory abnormalities, which could impair the ability to participate in the study or the interpretation of its results
研究者
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