NCT07359014招募中不适用
A Multicenter Clinical Study of Novel CD19/BCMA Dual-Targeted CAR-T Cell Therapy for the Treatment of Relapsed/Refractory Multiple Myeloma
Second Affiliated Hospital, School of Medicine, Zhejiang University0 个研究点目标入组 25 人开始时间: 2025年11月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
研究概览
简要总结
This study aims to investigate the efficacy and safety of CD19/BCMA CAR-T cells in treating relapsed/refractory multiple myeloma.
详细描述
B Cell Maturation Antigen (BCMA) Chimeric Antigen Receptor T-cell (CAR-T) therapy is currently a crucial treatment for relapsed/refractory multiple myeloma, yet approximately half of patients still experience relapse with limited subsequent treatment options. Recent studies suggest that dual-target CAR-T may offer new hope for relapsed/refractory multiple myeloma. Preliminary studies in this project demonstrate that the independently designed CD19/BCMA CAR-T exhibits potent anti-myeloma activity both in vitro and in tumor-bearing animal models, positioning it as a potential therapeutic strategy for relapsed/refractory multiple myeloma. Therefore, this study aims to investigate the efficacy and safety of CD19/BCMA CAR-T cells in treating relapsed/refractory multiple myeloma in humans, with the goal of providing novel therapeutic approaches for this disease.
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 multiple myeloma.
- •Confirmed by immunohistochemistry (IHC) or flow cytometry of bone marrow samples: plasma cell membrane expression of BCMA is positive (≥30%); no requirement for CD19 positivity rate. All sites must centrally submit bone marrow or plasmacytoma biopsy specimens to the lead site's pathology department or bone marrow/liquid specimens to KingMed Diagnostics (third-party laboratory) for BCMA expression verification.
- •Relapsed/refractory patients must meet the following criteria:
- •No response or disease progression after 3 cycles of bortezomib (proteasome inhibitor) or lenalidomide therapy No response or disease progression after 3 cycles of prior treatment regimen Interval between last treatment and disease progression >30 days No current indication for hematopoietic stem cell transplantation (HSCT), or patient refusal of HSCT
- •Definition of disease progression follows the 2021 International Myeloma Working Group (IMWG) criteria, meeting at least one of the following:
- •Serum M protein ≥ 5 g/L Urine M protein ≥ 200 mg/24 h If serum free light chain (FLC) ratio is abnormal, patient FLC level ≥ 100 mg/L Biopsy-confirmed evaluable plasmacytoma Increased myeloplasmacytic percentage ≥25% (absolute increase ≥10%) Myeloplasm cells constitute ≥30% of total bone marrow cells
- •Expected survival >12 weeks;
- •Disease status is evaluable and meets at least one of the following:
- •Serum M-protein ≥10 g/L, 24-hour urine M-protein ≥ 200 mg, Serum FLC ≥ 50 mg/L, Plasmacytoma evaluable by imaging or laboratory testing, Bone marrow plasma cell percentage ≥ 30%
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
- •Sufficient venous access for apheresis or venipuncture, with no other contraindications to blood cell separation;
- •white blood cell (WBC) ≥ 1.5 × 10⁹/L; platelet (PLT) ≥ 45 × 10⁹/L.
- •Serum creatinine ≤ 1.5 times the upper limit of normal (ULN).
- •Alanine Aminotransferase (ALT) ≤ 2.5 ULN, Aspartate Aminotransferase (AST) ≤ 2.5 ULN.
- •All laboratory values within the above ranges must be achieved without ongoing supportive therapy.
排除标准
- •Received systemic therapy such as cyclophosphamide and fludarabine for lymphoma clearance within 2 weeks prior to enrollment or single-cell collection; prior CD19/BCMA CAR-T therapy; or cell or bispecific antibody therapy within 8 weeks prior to treatment.
- •Received bendamustine-containing regimens within 6 months prior to treatment.
- •Hepatitis C virus (HCV) or Human Immunodeficiency Virus (HIV) positive status; any uncontrolled active infection, including active tuberculosis or Hepatitis B virus (HBV) DNA levels ≥1×10³ copies/mL.
- •Active infection within 72 hours prior to treatment initiation; subjects on ongoing prophylactic antibiotics, antifungals, or antivirals are not excluded provided there is no evidence of active infection and the antibiotics are not on the prohibited drug list.
- •Current systemic use of cyclosporine or steroids such as dexamethasone; recent or current use of inhaled steroids is not exclusionary.
- •Renal impairment with serum creatinine >1.5 times the upper limit of normal (ULN).
- •Hepatic impairment with AST and/or ALT >2.5 times ULN and direct bilirubin >1.5 times ULN.
- •Hyponatremia, serum sodium < 125 mmol/L.
- •Baseline serum potassium < 3.5 mmol/L (exclusion not applied if potassium supplementation prior to study enrollment restores levels above this threshold).
- •Pregnant or lactating women.
- •Other serious conditions that may preclude participation in this trial (e.g., central nervous system disorders, severe heart failure, myocardial infarction within the past 6 months, unstable arrhythmia or unstable angina, gastric ulcer, active autoimmune disease, etc.).
研究者
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