A Single-arm Prospective Study of Secondary Infusion of Relmacabtagene Autoleucel Injection for Relapsed or Refractory B-cell Lymphoma
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
To observe the efficacy and safety of a second infusion of relma-cel injection in patients with relapsed or refractory B-cell lymphoma.
详细描述
This study aims to collect efficacy and safety data from adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) who receive a second infusion of relma-cel injection after initial treatment with relma-cel. The study will not include any form of grouping, and subgroup analysis will be conducted based on the actual data collected.
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
- •Patients have signed an Informed Consent Form (ICF).
- •Adults diagnosed with relapsed or refractory B-cell lymphoma who have completed initial treatment with Relma-cel.
- •Patients must have undergone at least one disease assessment post-initial Relma-cel treatment, and the investigator decides to administer a second treatment (including PR/PD/SD) based on clinical practice.
- •Before the second infusion, confirm that the prepared dose of relma-cel is sufficient (recommended 80-150 x 10^6 CAR-T cells), with specific dosage determined by the investigator based on patient condition and dose availability.
- •Confirm the presence of CD19+ residual tumor tissue, if clinically permissible.
- •Measure plasma for the absence of anti-drug antibodies (ADA) to relma-cel before the second treatment.
- •Toxicity related to lymphodepleting chemotherapy (fludarabine and cyclophosphamide), except for hair loss, must have resolved to ≤ Grade 1 or returned to baseline levels before retreatment.
- •Patients must not have experienced severe adverse reactions during the first treatment, or any adverse reactions must have resolved to baseline levels from the first treatment.
排除标准
- •Patients with hypersensitivity to active ingredients or any excipients (e.g., dimethyl sulfoxide, compound electrolyte injection, human albumin).
- •Patients with uncontrolled systemic fungal, bacterial, viral, or other infections
研究组 & 干预措施
Relma-cel secondary infusion
干预措施: Relma-cel (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: 3 months post CAR-T infusion
ORR is defined as the percentage of participants achieving either CR or partial response (PR) per the Lugano Classification as determined by study investigators
次要结局
未报告次要终点
研究者
Zhao Weili
Vice president，Ruijin hospital
Ruijin Hospital