NCT06515262招募中不适用
A Clinical Study to Evaluate the Safety and Efficacy of BCMA-GPRC5D CAR-T in Patients With Relapsed/Refractory Multiple Myeloma Who Received Three or More Lines of Therapy
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence of adverse events(AE) after infusion
研究概览
简要总结
This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of bispecific BCMA-GPRC5D CAR-T cells in patients with relapsed or refractory multiple myeloma who received three or more lines of therapy.
详细描述
This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of bispecific BCMA-GPRC5D CAR-T cells in patients with relapsed or refractory multiple myeloma who received three or more lines of therapy.A leukapheresis procedure will be performed to manufacture Anti-BCMA-GPRC5D chimeric antigen receptor (CAR) modified T cells. Prior to Anti-BCMA-GPRC5D CAR-T cells infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide. After infusion, the safety and efficacy of CAR-T therapy was evaluated by investigators.
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
- •The patient or his/her guardian understands and voluntarily signs the informed consent, and is expected to complete the follow-up examination and treatment of the study procedure;
- •Age 18-75 years old, gender unlimited;
- •Diagnosed as Multiple Myeloma (MM) according to the international standard for multiple myeloma (IMWG);
- •The presence of measurable disease at screening meets one of the following criteria:Serum M-protein ≥ 1.0 g/dL or Urine M-protein ≥ 200 mg/24h or diagnosed as Light-chain MM without measurable disease in serum and urine; Serum free light chain ≥ 10 mg/dL with an abnormal κ/λ ratio;
- •Patients must relapse or be refractory after three or more lines of therapy, which at least include: one Proteasome Inhibitor (PI), one Immunomodulatory Drug (IMiD), and one anti-CD38 monoclonal antibody;
- •diagnosed as relapsed/refractory disease or primary refractory disease;
- •The last treatment is ineffective, or the disease progresses within 60 days after the end of the last therapy;
- •The patient has recovered from the toxicity of the prior treatment, i.e., CTCAE toxicity grade < 2 (unless the abnormality is related to the tumor or is stable as judged by the investigator and has little impact on safety or efficacy);
- •ECOG score 1-2 points and the expected survival period ≥ 3 months;
- •Liver, kidney and cardiopulmonary functions meet the following requirements:
- •Total bilirubin ≤ 1.5×ULN, alanine aminotransferase (ALT) ≤ 3 × ULN and aspartate aminotransferase (AST) ≤ 3 × ULN;
- •Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 60 mL/min;
- •Hemoglobin (Hb) ≥ 50 g/L without prior blood transfusion within 7 days;
- •Baseline peripheral oxygen saturation > 92%;
- •Corrected serum calcium ≤ 12.5 mg/dL (≤ 3.1 mmol/L) or free (ionized, ionic) calcium ≤ 6.5 mg/dL (≤ 1.6 mmol/L);
- •Left ventricular ejection fraction (LVEF) > 45%, without confirmed pericardiac effusion and abnormal electrocardiography with clinical significance;
- •Without clinically significant pleural effusion;
- •Venous access could be established; without contraindications of apheresis.
排除标准
- •Have been diagnosed with or treated for aggressive malignancies other than multiple myeloma;
- •Prior antitumor therapy (prior to blood collection for CAR-T preparation) : targeted therapy, epigenetic therapy, or investigational drug therapy within 14 days or at least 5 half-lives, whichever is shorter;
- •It is suspected that MM has involved the central nervous system or meninges and has been confirmed by MRI or CT, or there are other active central nervous system diseases;
- •Patients with Fahrenheit macroglobulinemia, POEMS syndrome, or primary AL, amyloidosis;
- •Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive; HIV antibody positive; CMV DNA titer is higher than the lower limit of detection of the research institution; EBV DNA titer is higher than the lower limit of detection of the research institution;
- •Patients have a severe allergic history;
- •Any unstable systemic disease: including but not limited to unstable angina, cerebrovascular accident or transient cerebral ischemia (within 6 months before screening), myocardial infarction (within 6 months before screening), congestive heart failure [New York Heart Association (NYHA) classification ≥ grade III];
- •Systemic diseases judged by researchers to be unstable: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
- •Patients with acute/chronic graft-versus-host disease (GVHD) or requiring immunosuppressive therapy for GVHD within 6 months prior to screening;
- •Active autoimmune or inflammatory diseases of the nervous system;
- •Patients develop oncology emergencies and need to be treated before screening or infusion;
- •Uncontrolled infections that need antibiotics treatment;
- •Exposure to hematopoietic growth factor of cells within 1-2 weeks before apheresis;
- •Exposure to Corticosteriods or immunosuppressive agents within 2 weeks before apheresis;
- •Patients receive a major surgical operation within 4 weeks before lymphodepletion or do not recover completely before the enrollment; or plan to receive a major surgical operation during the study period;
- •Live attenuated vaccine within 4 weeks before screening;
- •Persons with serious mental illness;
- •Alcoholics or persons with a history of drug abuse;
- •Pregnant or Lactating Women; Patients and his or her spouse have a fertility plan within two years after CAR-T cell infusion;
- •Any unsuitable to participate in this trial judged by the investigator.
结局指标
主要结局
Incidence of adverse events(AE) after infusion
时间窗: within 2 years after infusion
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome are graded by American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
次要结局
- Concentration of CAR-T cells(Days 1,4, 7, 10, 14 ,21,28and months 2, 3, 6, 9, 12,18,24 after infusion)
- Progression-free survival(PFS)(within 2 years after infusion)
- Overall survival(OS)(within 2 years after infusion)
- Overall Response Rate (ORR)(within 2 years after infusion)
研究者
研究点 (1)
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