A Clinical Study on the Safety and Efficacy of CAR19-BCMA Dual-target CAR-T Cell Therapy for Relapsed/Refractory Plasma Cell Neoplasms
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- According to the incidence of treatment-related adverse events (AEs) to evaluate the safetyof CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19+BCMA+plasma cell neoplasms.
研究概览
简要总结
This is a single arm study to evaluate the safety and efficacy of CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19/BCMA positive plasma cell neoplasms.
详细描述
This study is an exploratory clinical trial of a single-arm, open, single-center treatment of CAR19BCMA CAR-T cell. 20 subjects with relapsed or refractory CD19/ BCMA positive positive plasma cell neoplasms will be enrolled and received CAR19BCMA CAR T cells injection therapy, and related data such as adverse reactions and therapeutic effects after medication were followed up. To evaluate its safety and efficacy
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
- •Relapsed/refractory CD19BCMA positive plasma cell neoplasms must be assured and meet all of the following conditions:
- •1.1 Confirmation for either BCMA or CD19 positivity using immunohistochemistry or flow cytometry.
- •1.2 Patients with multiple myeloma, plasma cell carcinoma, and plasma cell leukemia who have received at least three 3 lines treatment (including anti-CD38 monoclonal antibodies, protease inhibitors, immunosuppressants, etc.) but have failed or experienced relapse.
- •1.3 Patients with system light chain amyloidosis who have received at least 2 lines treatments in the past [anti-CD38 monoclonal antibody, proteasome inhibitor (PI), or immunomodulatory drug (IMiD)], but have failed or experienced relapse.
- •Age 18-75 years,
- •no gender restrictions;
- •ECOG score ≤ 2 points;
- •Expected survival period is not less than 3 months;
- •Liver and kidney function and cardiopulmonary function meet the following requirements: (1) Creatinine ≤ 2× ULN; (2)left ventricular ejection fraction≥50%; (3) Oxygen saturation >90%; (4)Total bilirubin ≤1.5×ULN, ALT and AST≤2.5×ULN;
- •Participants agreed to use contraception from the time of informed consent until 1 year after CAR-T cell infusion.
排除标准
- •Severe heart failure with left ventricular ejection fraction <50%;
- •A history of severe lung function impairment; Combined with other advanced malignant tumors;
- •Complicated with severe infection that could not be effectively controlled;
- •Severe autoimmune disease or congenital immune deficiency;
- •Active viral hepatitis (defined as positive hepatitis B virus DNA [HBV-DNA] or hepatitis C virus RNA [HCV-RNA] detection, with test results exceeding the lower limit of quantification); Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
- •History of severe allergy to biological products (including antibiotics);
- •Allogeneic hematopoietic stem cell transplant patients who still have an acute graft-versus-host response (GVHD) one month after discontinuation of immunosuppressants;
- •Patients with other serious physical or mental illnesses or laboratory abnormalities that could increase the risk of participating in the study or interfere with the results of the study, and those who were deemed by the investigator to be unsuitable for participation in the study;
- •Female patients (those with fertility) are in pregnancy or lactation.
研究组 & 干预措施
This is a single arm treatment of CAR19BCMA CAR-T cell
干预措施: CAR19BCMA-T cells (Other)
结局指标
主要结局
According to the incidence of treatment-related adverse events (AEs) to evaluate the safetyof CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19+BCMA+plasma cell neoplasms.
时间窗: up to 3 years
Incidence of treatment-related adverse events (AEs) Description: Number and severity of adverse events graded according to CTCAE v5.0, including cytokine release syndrome (CRS) graded by ASTCT criteria and immune effector cell-associated neurotoxicity syndrome (ICANS) graded by ASBMT criteria
According to the determine the Maximal Tolerable Dose(MTD) to evaluate the safety of CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19+BCMA+ plasma cell neoplasms.
时间窗: MTD will be determined based on DLTs observed during the first 28 days of study treatment
次要结局
- According to the objective response rate (ORR) to evaluate the efficacy of CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19+BCMA+ plasma cell neoplasms.(Within 3 months following infusion of CAR19BCMA CAR-T cells)
研究者
Chunji Gao
Principal Investigator
Chinese PLA General Hospital