A Clinical Study of the Safety and Efficacy of Chimeric Antigen Receptor-modified T Cells Targeting BCMA for the Treatment of Relapsed/Refractory Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Complete remission rate (CR)
研究概览
简要总结
To evaluate the safety and tolerability of chimeric antigen receptor gene-modified T cells targeting BCMA for the treatment of relapsed/refractory multiple myeloma
详细描述
Subjects who meet the eligibility criteria, PBMC will be collected by blood cell separator and 50 mL of plasma will be collected for preparation of CAR-T and frozen storage of CAR-T preparations; patients will be treated with autologous BCMA CAR-T transfusion and followed up for a period of 3 years, with specific efficacy judgments referring to the IMWG Clinical Efficacy Evaluation Criteria.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years, no gender restrictions;
- •Diagnosed with refractory/relapsed multiple myeloma through physical examination, pathological examination, laboratory tests, and imaging studies;
- •Flow cytometry or histology confirms positive BCMA expression in myeloma cells;
- •As judged by the investigator, the expected survival time is >3 months;
- •ECOG performance status score ≤2, KPS >60%;
- •The patient has good liver, kidney, heart, and lung function: ALT and AST ≤2.5×ULN, those with liver involvement can be relaxed to ≤5×ULN; serum total bilirubin <34 μmol/L; creatinine clearance rate >30 mL/min; heart ejection fraction (EF) ≥40%, no pericardial effusion and significant arrhythmia; indoor SpO2 ≥92%;
- •Peripheral blood lymphocyte absolute count ALC ≥0.5 ×10^9/L, PLT >30×10^9/L, Hb >80 g/L and has a single collection venous access, and there are no other contraindications for hematopoietic cell separation;
- •Those with fertility must agree to use highly effective contraceptive methods;
- •The subject or their legal guardian can understand and is willing to sign a written informed consent form voluntarily.
排除标准
- •Pregnant or nursing women, as well as women planning to become pregnant within the next six months;
- •Positive virology tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus;
- •History of other tumors (except for those with skin or cervical in situ cancers that have been cured by radical treatment and show no evidence of disease activity);
- •Previously received treatment targeting BCMA;
- •Underwent autologous hematopoietic stem cell transplantation within the last 6 weeks;
- •Presence of uncontrolled active bacterial or fungal infection;
- •Allergic to research-related drugs or cell components;
- •Presence of active autoimmune diseases;
- •Currently have unstable or active ulcers or gastrointestinal bleeding;
- •Unable to cooperate with treatment and efficacy evaluation due to mental or psychological disorders;
- •Received other experimental drug treatments within the last 3 months;
- •The researcher believes that for other reasons, the individual is not suitable for the clinical trial.
研究组 & 干预措施
CAR-T
干预措施: CAR-T treatment (Biological)
结局指标
主要结局
Complete remission rate (CR)
时间窗: Up to 36 months
Negative serum and urine immunofixation electrophoresis, disappearance of soft tissue plasmacytoma, and less than 5% plasma cells in the bone marrow. For patients who rely solely on serum FLC levels as a measurable lesion, in addition to meeting the above CR criteria, it is also required that the ratio of serum FLC is restored to normal in two consecutive evaluations.
次要结局
- Adverse events (AE)(Up to 36 months)
研究者
Bing, Xu
Principal Investigator
The First Affiliated Hospital of Xiamen University