NCT05302648进行中（未招募）早期 1 期
A Early Phase 1 Clinical Trial to Evaluate the Safety and Efficacy of Human Derived Anti-BCMA CAR-T Injection for Subjects with Relapsed/Refractory Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Dose limited toxicity(DLT)
研究概览
简要总结
This study is a single-arm, open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of Human Derived anti-BCMA CAR-T Injection , and to preliminarily observe the efficacy of the trial drug in patients with relapsed/refractory multiple myeloma.
详细描述
Subjects withe relapsed/refractory multiple myeloma can participate if all eligibility criteria are met. Tests required to determine eligibility including disease assessments, a physical exam, Electrocardiograph, Computed tomography（CT）/Magnetic Resonance Imaging(MRI)/Positron Emission Tomography（PET）,liver/renal function tests, complete blood count with differential and complete metabolic profile and etc.. Subjects will receive precondtioning chemotherapy prior to the infusion of BCMA CAR- T cells. After the infusion, subjects will be followed for adverse events pharmacokinetic/pharmacodynamics characteristics, efficacy, of BCMA CAR-T cells. Study procedures may be performed while hospitalized.
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
- •Subjects must meet all of the following criteria to be enrolled:
- •Subjects volunteer to participate in clinical trails, understand and inform the trials and sign informed consent form, be willing to complete all the trial procedures;
- •18 to 75 years old (including cut-off value), Male and female;
- •Expected survival > 12 weeks;
- •Previously diagnosed as multiple myeloma by IMWG updated criteria (2014);
- •One of the following indicators is satisfied:
- •Serum M protein: for immunoglobulin G (IgG) type , M protein≥ 10 g/L, or for immunoglobulin A (IgA) type , M protein > 5g/L, or for immunoglobulin D (IgD) type , M protein, IgD exceeds upper limit of normal range.
- •Urine M protein ≥ 200 mg/24h;
- •Serum free light chain ≥ 100 mg/L and Serum free light chain ratio is abnormal ;
- •Patients with relapsed/refractory multiple myeloma. Relapsed is defined as: Patients have disease progression after at least three-line treatment regimens. Patients previously received at least 3 different mechanisms treatment regimens for multiple myeloma, including protease inhibitors and immunomodulators; Refractory is defined as: Patients who achieved minimal response(MR) or above was never achieved in previous treatment; MR or above was achieved in previous treatment, but disease progression occurred during subsequent treatment or within 60 days after the last treatment.
- •ECOG score 0-2;
- •Liver, kidney and cardiopulmonary functions meet the following requirements:
- •Creatinine clearance (estimated by Cockcroft Gault formula) ≥ 40 mL/min;
- •Left ventricular ejection fraction >50%;
- •Baseline peripheral oxygen saturation >95%;
- •Total bilirubin ≤ 2×ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN;
- •The venous access required for collection can be established and leukepheresis can be carriedaccording to the judgement of investigators.
排除标准
- •Any one of the following conditions cannot be selected as a subject：
- •Accompanied by other uncontrolled malignancies;
- •Subjects with positive Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) and peripheral blood Hepatitis B virus(HBV) DNA titer is ≥500IU/mL; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus(HIV) antibody positive; syphilis primary screening antibody positive;
- •Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure （New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease;
- •Patients who are accounted to be not appropriate for this trail by investigator;
- •Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion;
- •Received CAR-T treatment or other gene therapies before enrollment;
- •Those who failed to sign informed consent form or comply with the research procedures; Unwilling or unable to comply with research requirements;
- •Have had severe immediate hypersensitivity reactions to any drugs used in this research;
- •Active or uncontrollable infection requiring systemic therapy within 14 days prior to enrollment;
- •In the past two years, the terminal organ was damaged due to autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus), or the systemic use of immunosuppressive or other systemic disease control drugs was required;
- •Patients with symptoms of central nervous system.
研究组 & 干预措施
Human Derived anti-BCMA CAR-T Injection
Experimental
Single administration：1.0×10^6 CAR+T, 3.0×10^6 CAR+T, 6.0×10^6 CAR+T
干预措施: Human Derived anti-BCMA CAR-T Injection (Drug)
结局指标
主要结局
Dose limited toxicity(DLT)
时间窗: 28 days post infusion
Safety Indicator
次要结局
- Pharmacokinetics parameters -Time to peak CAR level in blood (Tmax)(2 years post infusion)
- Pharmacodynamics characteristics -Clonal bone marrow plasma cells level(2 years post infusion)
- Number of Subjects with Adverse Events(2 years post infusion)
- Change from Baseline in Physical Exam(2 years post infusion)
- Pharmacokinetics parameters - Maximum CAR level in blood and CAR level in bone marrow(Cmax)(2 years post infusion)
- Pharmacokinetics parameters - 28-day Area under the curve of the CAR level in blood(AUC0-28)(2 years post infusion)
- Pharmacodynamics characteristics - Cytokines Concentrations,cytokines level in blood(2 years post infusion)
- Percentage of Subjects With Negative Minimal Residual Disease (MRD)(2 years post infusion)
- Duration of Subjects With Negative Minimal Residual Disease (MRD)(2 years post infusion)
- Change from Baseline in Perform Status as Measured by Eastern Cooperative Oncology Group（ECOG）Score（0-4）(2 years post infusion)
- Overall Response Rate (ORR) at 3 month post infusion(3 month post infusion)
- Overall Survival (OS)(2 years post infusion)
- Change from Baseline in complete blood count with differential and blood biochemical examination(2 years post infusion)
- Progression-free Survival (PFS)(2 years post infusion)
- Duration of Response (DOR)(2 years post infusion)
研究者
研究点 (1)
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