EUCTR2016-003893-42-GB进行中（未招募）1 期
A Single Arm, Open-Label, Multi-Centre, Phase I/II Study Evaluating the Safety and Clinical Activity of AUTO2, a CAR T Cell Treatment Targeting BCMA and TACI, in Patients with Relapsed or Refractory 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
- 80
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
入选标准
- •1. Male or female patients, aged = 18.
- •2. Willing and able to give written, informed consent for the current study protocol AUTO2-MM1.
- •3. Confirmed diagnosis of MM.
- •4. Measurable disease as defined by any 1 of the following:
- •- Serum M-protein = 500 mg/dL;
- •- Urine M-protein = 200 mg/24 hours;
- •- Involved serum free light chain level = 10 mg/dL, provided serum free light chain ratio is abnormal.
- •5.Relapsed or refractory disease after either one of the following:
- •a. Relapse or refractory disease and have had at least 3 different prior lines of therapy including proteasome inhibitor (e.g. bortezomib or carfilzomib) and immunomodulatory therapy (IMiD; e.g. thalidomide, lenalidomide or pomalidomide) and alkylator or monoclonal antibody.
- •b. have double refractory disease to a proteasome inhibitor and IMiD, defined as progression on or within 60 days of receiving these agents.
- •6. For females of childbearing potential (defined as < 2 years after last menstruation or not surgically sterile), a negative serum or urine pregnancy test must be documented at screening, prior to pre-conditioning and confirmed before receiving the first dose of study treatment.
- •7. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1.
- •8. Peripheral blood total lymphocyte count > 0.5 x 10e9/L at enrolment and prior to leukapheresis
- •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 33
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 47
排除标准
- •1. Women who are pregnant or lactating.
- •2. Prior treatment with investigational or approved gene therapy or cell therapy products.
- •3. Clinically significant, uncontrolled heart disease (New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, sick-sinus syndrome, or electrocardiographic evidence of acute ischaemia or Grade 3 conduction system abnormalities unless the patient has a pacemaker) or a recent (within 6 months) cardiac event.
- •4. Left Ventricular Ejection fraction < 50 (by ECHO or MUGA) unless the institutional lower limit of normal is lower.
- •5. Patients with a history or evidence of deep vein thrombosis or pulmonary embolism requiring ongoing therapeutic anticoagulation at the time of pre-conditioning.
- •6. Patients with any major surgical intervention in the last 3 months, cement augmentation for vertebral collapse is permitted.
- •7. Significant liver disease: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 3 × ULN, or total bilirubin =25 µmol/L (1.5 mg/dL), except in patients with Gilbert’s syndrome or evidence of end stage liver disease (e.g. ascites, hepatic encephalopathy).
- •8. Chronic renal impairment requiring dialysis, or calculated creatinine clearance < 30 mL/min.
- •9. Active infectious bacterial or viral disease (hepatitis B virus, hepatitis C virus, human immunodeficiency virus, human T-lymphotropic virus or syphilis) requiring treatment.
- •10. Use of rituximab (or rituximab biosimilars) within the last 3 months prior to AUTO2 infusion.
- •11. Active autoimmune disease requiring immunosuppression.
- •12. Received any anti-myeloma therapy within the last 7 days prior to pre-conditioning or leukapheresis. Growth factors should stop 10 days prior to leukapheresis.
- •13. Received any radiotherapy within the last 7 days prior to pre-conditioning or leukapheresis. Localised radiation to a single site, e.g. for bone pain is permitted at any time.
- •14. Life expectancy < 3 months.
- •15. Known allergy to albumin, dimethyl sulfoxide, cyclophosphamide or fludarabine.
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不适用
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