EUCTR2013-001418-13-FI进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 346
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+ haematological 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) who have progressed on or after standard therapy that includes an IMiD and a proteasome inhibitor 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 (=0.5 g/dL in case of IgA disease for stage 2), or urine M-protein =200 mg/24 hours or in the absence of measurable m-protein, serum FLC =10 mg/dL, and abnormal serum immunoglobulin kappa lambda FLC ratio (<0.26 or >1.65).
- •-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.
- •-Stage 2 only : Patients must have evidence of disease progression on or after
- •the most recent prior regimen based on IMWG criteria.
- •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 171
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 170
排除标准
- •- Karnofsky performance status <60.
- •- Poor bone marrow reserve.
- •- Poor organ function.
- •-Known intolerance to infused protein products, sucrose, histidine, polysorbate 80 or known hypersensitivity to any of the components of the study therapy that is not amenable to pre-medication with steroids and H2 blockers.
- •-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 immunoglobulin M (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 (stage 1)/ECOG Performance status >2 (stage 2)
- •-Poor bone marrow reserve.
- •-Poor organ function.
- •-Known intolerance to infused protein products, sucrose, histidine, polysorbate
- •80 or known hypersensitivity to any of the components of the study therapy that
- •is not amenable to pre-medication with steroids and H2 blockers.
- •-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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