A Multicenter, Open-label, Single-arm Clinical Study of Anti-BCMA CAR-T Cell Therapy in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This is a prospective study of anti-BCMA CAR-T in transplant-ineligible patients with newly diagnosed multiple myeloma.
详细描述
After the diagnosis of multiple myeloma (MM), patients were stratified by frailty status. Frail patients received 4 cycles of VRd regimen (bortezomib, lenalidomide, and dexamethasone), while non-frail patients received 4 cycles of DVRd regimen (daratumumab, bortezomib, lenalidomide, and dexamethasone). Following induction therapy, peripheral blood lymphocytes were collected to manufacture anti-BCMA CAR-T cells. After lymphodepletion with the FC regimen (fludarabine and cyclophosphamide), patients received a single infusion of anti-BCMA CAR-T cells at a target dose of 2.0 × 10^6 CAR-positive cells per kilogram of body weight. Peripheral blood samples were collected at regular intervals to assess treatment efficacy, safety, and CAR-T cell expansion and persistence. Patients were closely monitored for 6 months post-infusion. Thereafter, disease assessments, physical examinations, and hematologic tests were conducted every 3 months for a total follow-up duration of 2 years.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years (inclusive);
- •Estimated life expectancy of more than 12 weeks;
- •Diagnosis of multiple myeloma confirmed by physical examination, pathological evaluation, laboratory tests, and imaging studies;
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels less than 3 times the upper limit of normal (ULN);
- •Karnofsky Performance Status (KPS) score > 50%.
- •Ineligible for ASCT.
排除标准
- •Pregnant or lactating women, or women planning to become pregnant within the next six months;
- •Transduction efficiency of targeted lymphocytes <10%, or expansion fold <5× under CD3/CD28 co-stimulation, as determined by feasibility screening;
- •History of severe allergies or hypersensitivity, especially to interleukin-2 (IL-2);
- •Significant dysfunction of vital organs including the heart, lungs, or brain;
- •Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study
研究组 & 干预措施
CAR-T
CAR-T alone
干预措施: CAR-T (Biological)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Up to 36 months after CAR-T infusion
Progression-Free Survival (PFS) is defined as the time from the date of CAR-T cell infusion to the date of disease progression or death from any cause, whichever occurs first. Disease progression will be determined based on the International Myeloma Working Group (IMWG) criteria. Patients who have not progressed or died will be censored at the date of last follow-up.
Overall Survival (OS)
时间窗: Up to 36 months after CAR-T infusion
Overall Survival (OS) is defined as the time from the date of CAR-T cell infusion to death from any cause. Patients who are alive at the time of analysis will be censored at their last known date of follow-up.
次要结局
- Objective Response Rate (ORR)(Up to 36 months after CAR-T infusion)
- MRD(Up to 36 months after CAR-T infusion)
- Adverse Events (AE)(Up to 36 months after CAR-T infusion)
研究者
Kai Lin Xu，MD
Chief Hematologist of The Affiliated Hospital of Xuzhou Medical University
Xuzhou Medical University