EUCTR2020-003248-10-ES进行中（未招募）1 期
An exploratory phase 1/2 trial to determine recommended phase 2 dose (RP2D), safety and preliminary efficacy of bb2121 (ide-cel) combinations in subjects with refractory/relapsed 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
- 334
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
- •1.Subject has documented diagnosis of MM and measurable disease, defined as:
- •a.M-protein (serum protein electrophoresis [sPEP] or urine protein electrophoresis
- •[uPEP]): sPEP = 0.5 g/dL or uPEP = 200 mg/24 hours and/or
- •b.Light chain MM without measurable disease in the serum or urine: Serum immunoglobulin free light chain = 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio
- •2.Subject has received:
- •a.at least 3 prior MM regimens for Arm A Cohort 1 and Arm B
- •b.at least 1 but no greater than 3 prior MM regimens for Arm A Cohort 2 and Arm C.
- •Note: induction with or without hematopoietic stem cell transplant and with or without consolidation therapy and with or without maintenance therapy is considered as one regimen.
- •3.Arm A Cohort 1 and Arm B: Subject has received prior treatment with an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody-containing regimen for at least 2 consecutive cycles.
- •4.Arm A Cohort 2 and Arm C: Subject has received prior treatment with an immunomodulatory agent for at least 2 consecutive cycles.
- •5.Evidence of PD during or within 6 months (measured from the last dose of any drug within the regimen) of completing treatment with the last antimyeloma regimen before study entry.
- •6.Subject achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen.
- •Other Protocol defined Inclusion criteria apply.
- •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 217
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 117
排除标准
- •1. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent participation to the study.
- •2.Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- •3. Subject has any condition that confounds the ability to interpret data from the study.
- •4.Subject has any of the following laboratory abnormalities (refer to Protocol for exhaustive list)
- •5.Echocardiogram (ECHO) or multigated acquisition (MUGA) with left ventricular ejection fraction (LVEF) < 45% and for subjects in Treatment Arm A an electrocardiogram (ECG) with corrected QT interval (QTc) of > 470 milliseconds at Screening.
- •6.Ongoing treatment with chronic immunosuppressants (eg, cyclosporine or systemic steroids at any dose). Intermittent topical, inhaled or intranasal corticosteroids are allowed.
- •7.Subject is positive for human immunodeficiency virus (HIV), chronic or active hepatitis B or active hepatitis A or C.
- •8.Subject has systemic and uncontrolled fungal, bacterial, viral or other infection. Uncontrolled defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antimicrobial treatment) or requiring IV antimicrobials for management
- •9.Subject with a history of clinically significant cardiovascular disease within the past 6 months of signing the ICF: Class III or IV heart failure as defined by the New York Heart Association (NYHA), severe non ischemic cardiomyopathy, myocardial infarction, unstable or poorly controlled angina, uncontrolled severe hypertension, severe uncontrolled cardiac arrhythmias (Grade 3 or higher) or other clinically significant cardiac disease.
- •Other protocol-defined exclusion criteria apply
研究者
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