A Phase I Trial of B-cell Maturation Antigen (BCMA) Targeted EGFRt/BCMA-41BBz Chimeric Antigen Receptor (CAR) Modified T Cells With or Without Lenalidomide for the Treatment of Multiple Myeloma (MM)

Memorial Sloan Kettering Cancer Center1 个研究点分布在 1 个国家目标入组 20 人2017年2月27日

适应症Multiple Myeloma

干预措施EGFRt/BCMA-41BBz CAR T cell Cyclophosphamide Lenalidomide.

概览

阶段: 1 期
干预措施: EGFRt/BCMA-41BBz CAR T cell
疾病 / 适应症: Multiple Myeloma
发起方: Memorial Sloan Kettering Cancer Center
入组人数: 20
试验地点: 1
主要终点: MTD of gene-modified T cells
状态: 进行中（未招募）
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The purpose of this phase I clinical trial is to test the safety of these CAR T cells in patients with myeloma.

There are two parts of this study. Part 1 of the study consists of screening for BCMA, Lenalidomide assignment and cell collection. Part 2 of the study is treatment with modified CAR T cells.

注册库

clinicaltrials.gov

开始日期

2017年2月27日

结束日期

2027年2月1日

最后更新

上个月

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Memorial Sloan Kettering Cancer Center

责任方

Sponsor

入排标准

入选标准

•Patients must have histologically confirmed MM by MSKCC pathologist, with MM cells expressing BCMA, previously treated with 2+ prior lines of therapy including an IMiD and a PI, either with refractory, persistent, or progressive disease
•Age ≥ 18 years of age
•Creatinine ≤2.0 mg/dL, direct bilirubin ≤2.0 mg/dL, AST and ALT ≤3.0x upper limit of normal (ULN)
•Adequate pulmonary function as assessed by ≥92% oxygen saturation on room air by pulse oximetry.
•HGB≥7g/dl, ANC≥1,000/mm3, Platelet≥30,000/mm3 without transfusion or growth factor support for at least 1 week
•M spike ≥0.5 g/dL or involved free light chain ≥10 mg/dL with an abnormal free light chain ratio

排除标准

•Karnofsky performance status \<70
•Pregnant or lactating women. Women and men of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished
•Impaired cardiac function (LVEF \<40%) as assessed by ECHO or MUGA scan
•Patients with following cardiac conditions will be excluded:
•New York Heart Association (NYHA) stage III or IV congestive heart failure
•Myocardial infarction ≤6 months prior to enrollment
•History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
•History of severe non-ischemic cardiomyopathy
•Patients with HIV or active hepatitis B or hepatitis C infection are ineligible
•Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of skin

研究组 & 干预措施

BCMA Targeted CAR T Cells with or without Lenalidomide

干预措施: EGFRt/BCMA-41BBz CAR T cell

BCMA Targeted CAR T Cells with or without Lenalidomide

干预措施: Cyclophosphamide

BCMA Targeted CAR T Cells with or without Lenalidomide

干预措施: Lenalidomide.

结局指标

主要结局

MTD of gene-modified T cells

时间窗: 36 months

The MTD is defined as the highest dose with an observed incidence of DLT in no more than one out of six patients treated at a particular dose level. T cell dose may be divided in up to three infusions administered over up to 7 days.