NCT04309981进行中（未招募）1 期
Pilot Study of the Infusion of Differentiated Autologous T-cells From Peripheral Blood, Expanded and Transduced With a Lentivirus to Express a Chimeric Antigen Receptor With Anti-BCMA (TNFRSF17) Specificity Humanized Conjugated With the Co-stimulatory Region 4-1BB and Signal-transduction CD3z (ARI0002h) in Patients With Relapsed/Refractory Multiple Myeloma With Previous Treatment With Proteasome Inhibitor, Immunomodulatory Drug and Anti-CD38 Monoclonal Antibody
Sara V. Latorre14 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2020年5月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 73
- 试验地点
- 14
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
To assess the safety and efficacy of CARTBCMA ARI0002h in patients with relapsed/refractory multiple myeloma who have received treatment with proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the age of 18 and 75 years with diagnosis of multiple myeloma
- •Disease measurable by monoclonal component in serum and/or urine or by free light chains in serum according to the eligibility criteria for clinical trials of the International Myeloma Working Group
- •Previous two or more lines of treatment. Patients must have received at least a proteasome inhibitor (such as bortezomib or carfilzomib), an immunomodulatory drug (lenalidomide or pomalidomide) and an anti-CD38 monoclonal antibody (such as daratumumab)
- •Refractory to the last line of treatment
- •ECOG functional status ranging from 0 to 2
- •Life expectancy over 3 months
- •Patients who, after being informed, give their consent by signing the Informed Consent document.
排除标准
- •Previous allogeneic transplant in the prior 6 months to inclusion or GVHD that requires active systemic immunosuppressive treatment
- •Absolute lymphocyte count <0.1x10^9/ L
- •Previous neoplasia, except if patients have been in complete remission > 3 years, except for cutaneous carcinoma (non-melanoma)
- •Active infection that requires treatment
- •Active infection by HIV, HBV or HCV.
- •Uncontrolled medical disease
- •Severe organic condition that meets any of the following criteria: EF <40%, DLCO <40%, EGFR <50 ml / min, bilirubin> 3 times normal value (except Gilbert syndrome)
- •Previous diagnosis of symptomatic AL amyloidosis
- •Pregnant or lactating women. Women of childbearing age should have a negative pregnancy test in the screening phase
- •Women of childbearing age, including those whose last menstrual cycle was in the year prior to screening, who cannot or do not wish to use highly effective contraceptive methods from the beginning until the end of the study.
- •Men who cannot or do not wish to use highly effective contraceptive methods from the beginning to the end of the study.
- •Contraindication to receive conditioning chemotherapy
结局指标
主要结局
Overall response rate (ORR)
时间窗: 3 months
Cytokine release syndrome rate
时间窗: within 30 days of first infusion
次要结局
- Duration of the response(up to 36 months after treatment)
- Time to complete response(up to 36 months after treatment)
- Expression of BCMA(at screening, at day +28, at day +100, at month 6, 12, 18 and 24)
- Levels of soluble BCMA in serum(at screening, at day 0, +3, +7,+14,+28, +70 +100, at month 4, 5, 6, 7, 8, 9, 1,11, 12, 18 and 24)
- Response rate(over the first year)
- Response rate of extramedullary disease by PET-TC(at month 3)
- Presence of tumor lysis syndrome(up to 36 months after treatment)
- Presence of neurological toxicity(up to 36 months after treatment)
- Persistence of CART BCMA ARI0002 in peripheral blood(month 1, 2, 3, 4, 5, 6 and every 6 months until 2 years of follow up)
- Complete response rate (CR)(at month 3 and month 6 of first infusion)
- Overall response rate (ORR)(at month 6 of first infusion)
- Response rate of extramedullary disease by PET-CT(up to 36 months after treatment)
- Negative MRD rate in bone marrow(at month 3 and month 6 of first infusion)
- Progression free survival (PFS)(at month 12, and up to 36 months after treatment)
- Overall survival (OS) defined as the time elapsed between the infusion of ARI0002h and the death of the patient from any cause(up to 36 months after treatment)
- Presence of cytokine release syndrome(up to 36 months after treatment)
- Presence of prolonged cytopenia(up to 36 months after treatment)
研究者
Sara V. Latorre
Clinical Research Manager
Institut d'Investigacions Biomèdiques August Pi i Sunyer
研究点 (14)
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