A Study of DeepTag-GPRC5D Targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
Clinical Trial for the safety and efficacy of DeepTag-GPRC5D targeted CAR-T cells therapy for refractory/relapsed multiple myeloma
详细描述
In this study, 60 patients with relapsed refractory multiple myeloma were proposed to undergo DeepTag-GPRC5D CAR-T cell therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of DeepTag-GPRC5D CAR-T cell therapy for relapsed refractory multiple myeloma; At the same time, on the basis of expanding the sample size, more safety data on DeepTag-GPRC5D CAR-T cell treatment for relapsed refractory multiple myeloma were accumulated, including rare and delayed complications.
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
- •* 1. Those who voluntarily participated in this trial and provided informed consent;
- •* 2. Gender unlimited，18\0.3×10e9/L;
- •2. Neutrophils ≥0.5×10e9/L;
- •3. Hemoglobin ≥60g/L;
- •4. Platelet ≥30×10e9/L
排除标准
- •History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
- •Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- •Pregnant (or lactating) women;
- •Patients with HIV infection;
- •Active infection of hepatitis B virus or hepatitis C virus;
- •Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
- •The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
- •Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;
- •Any situations that the investigator believes may increase the risk of patients or interfere with the results of study;
- •Patients who received anti-cancer chemotherapy or other medications within 2 weeks before screening;
- •Uncontrolled malignant tumors except MM, excluding malignant tumors that received radical treatment and no active disease was found within 3 years before enrollment;
- •Patients who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks before screening, or who plan to undergo ASCT during the study period;
- •Patients received allogeneic stem cell therapy;
- •Any unsuitable to participate in this trial judged by the investigator.
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: Up to 28 years after Treatment
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Up to 2 years after Treatment
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
次要结局
- Multiple Myeloma (MM), Overall response rate (ORR)(Up to 2 years after Treatment)
- Progression-free survival (PFS)(Up to 2 years after Treatment)
- Duration of remission,DOR(Up to 1 years after Treatment)
研究者
He Huang
Clinical Professor
Zhejiang University