NCT06976437招募中1 期
An Exploratory Clinical Study on the Safety and Efficacy of Allogeneic CD19/BCMA CAR-T Cell Treatment for Relapsed/ Refractory B-cell or Plasma Cell-derived Malignant Tumors
YANRU WANG1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2025年5月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events after RN1101 infusion
研究概览
简要总结
A single arm, open-label pilot study is designed to determine the safety and efficacy of CD19 and B-cell maturation antigen (BCMA) targeted allogenic CAR-T cells (RN1101) in patients with relapsed/refractory B-cell or plasma cell-derived malignant tumors. 21 patients are planned to be enrolled in the dose-escalation trial. The primary objective of the study is to evaluation of the safety and feasibility of RN1101 for the treatment of relapsed/refractory B-cell or plasma cell-derived malignant tumors. The secondary objective is to evaluate the efficacy of RN1101 for the treatment of relapsed/refractory B-cell or plasma cell-derived malignant tumors. The exploratory objective is to evaluate expansion, persistence and ability of RN1101 to deplete CD19 or BCMA positive cells in patients with relapsed/refractory B-cell or plasma cell-derived malignant tumors.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness to participate in the trial and provision of signed informed consent.
- •Patients diagnosed with B-lymphocyte or plasma cell-derived malignancies as per the 2017 revised WHO criteria, including acute B-lymphoblastic leukemia (B-ALL), and mature B-cell lymphomas such as diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), small lymphocytic lymphoma/chronic lymphocytic leukemia (SLL/CLL), mantle cell lymphoma (MCL), multiple myeloma (MM), etc.
- •Refractory or recurrent B-lymphocyte or plasma cell-derived malignancies, defined as failure to achieve complete remission after standard treatment, or relapse during follow-up after achieving remission with first-line or salvage therapy.
- •Patients with B-cell acute lymphoblastic leukemia (ALL) who have achieved hematologic remission but have persistent minimal residual disease (MRD).
- •According to the revised International Working Group (IWG) criteria, relapsed/refractory lymphoma patients must have at least one measurable lesion with a longest diameter ≥1.5 cm.
- •18 Years and older, regardless of gender.
- •An expected survival of ≥12 weeks.
- •Serum total bilirubin level < twice the upper limit of normal, serum creatinine level < upper limit of normal, serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < three times the upper limit of normal.
- •Absolute neutrophil count ≥0.5×10⁹/L, platelets ≥20×10⁹/L; for B-lymphocyte malignancies with definitive bone marrow involvement, no requirements for neutrophil and platelet counts.
- •ECOG performance status of 0 -
- •Left ventricular ejection fraction (LVEF) ≥50% and no pericardial effusion.
- •At least 2 weeks have passed since the last treatment (radiotherapy, chemotherapy, monoclonal antibody therapy, or other treatments).
排除标准
- •Known allergies, hypersensitivity, intolerance, or contraindications to CD19/BCMA allogenic CAR-T or any components of the trial drugs (including fludarabine, cyclophosphamide, and rituximab), or a history of severe allergic reactions.
- •Recurrence after allogeneic hematopoietic stem cell transplantation with active graft - versus - host disease (GVHD) requiring steroid or immunosuppressive therapy.
- •Severe active infection.
- •Acquired or congenital immunodeficiency.
- •New York Heart Association (NYHA) Class Ⅲ or Ⅳ heart failure.
- •History of epilepsy or other central nervous system diseases.
- •Lymphoma with extranodal involvement of the brain, lungs, or gastrointestinal tract.
- •Other primary cancers, except:
- •Non-melanoma skin cancer (e.g., basal cell carcinoma) cured by resection.
- •Carcinoma in situ (e.g., cervical, bladder, or breast cancer) cured.
- •Systemic high-dose steroids within 2 weeks before treatment.
- •Pregnant, breastfeeding, or plans to become pregnant within 6 months.
- •Participation in another clinical trial within the past month.
- •Any situation the investigator deems may raise risks or interfere with trial results.
研究组 & 干预措施
RN1101 treatment
Experimental
CD19+ or BCMA+ r/r B Cell lymphoma or multiple myeloma (MM) patients to be treated with a single dose of RN1101 cells.
干预措施: RN1101 injection (Drug)
结局指标
主要结局
Incidence and severity of adverse events after RN1101 infusion
时间窗: up to 24 weeks after RN1101 infusion
次要结局
- Percentage of MRD negative patients after RN1101 treatment(12 weeks, 24 weeks after RN1101 infusion)
- ORR (PR, VGPR, CR and sCR) of patients receive RN1101 treatment(12 weeks, 24 weeks after RN1101 infusion)
- Progression free survival after RN1101 treatment(12 weeks, 24 weeks after RN1101 infusion)
- CAR copies and cell count of CAR-T in blood and bone marrow (if available) after RN1101 treatment(12 weeks, 24 weeks after RN1101 infusion)
- Duration of response after RN1101 treatment(12 weeks, 24 weeks after RN1101 infusion)
- Overall survival after RN1101 treatment(12 weeks, 24 weeks after RN1101 infusion)
研究者
YANRU WANG
Doctor
Affiliated Hospital of Jiangsu University
研究点 (1)
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