A Clinical Study on the Safety and Effectiveness of Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-ALL
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
A Clinical Study on the Safety and Effectiveness of targeting CD5 CAR-T Cells in the treatment of r/r CD5+ T-ALL
详细描述
In this study, 30 patients with relapsed refractory T-ALL were proposed to undergo CD5 CAR-T Cells therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD5 CAR-T Cells therapy for relapsed refractory T-ALL; At the same time, on the basis of expanding the sample size, more safety data on CD5 CAR-T Cells treatment for relapsed refractory T-ALL were accumulated.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphocytic Leukemia (
- •v1), patients diagnosed as CD5+T-ALL;
- •Consistent with r/r CD5+T-ALL diagnosis, including any of the following conditions:
- •No CR after standard chemotherapy;
- •The first induction reaches CR, but CR ≤ 12 months;
- •Patients with r/r CD5+T-ALL have not responded to the first or multiple remedial treatments;
- •c.Multiple recurrences.
- •CD5 expression rate was >90%;
- •Number of blasts in the bone marrow (protolychic + larvae) >5% (morphology) and/or >1% (flow cytometry);
- •Total bilirubin ≤51 (mol/L), Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) ≤ 3 times the upper limit of the normal range, creatinine ≤176.8 (mol/L);
- •Echocardiography showed left ventricular ejection fraction (LVEF) ≥50%;
- •7.Refers to the pulse oxygen saturation 92% or higher oxygen (state);
- •8.Estimated life expectancy of minimum of 12 weeks;
- •9.ECOG 0-2;
- •10.Pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period;
- •Those who voluntarily participated in this trial and provided informed consent;
排除标准
- •1.Patients with the history of epilepsy or other CNS disease;
- •Patients with prolonged QT interval time or severe heart disease;
- •Active infection of hepatitis B virus, C virus or hepatitis E virus;
- •Active infection with no cure;
- •Before using any gene therapy products;
- •Received anti-tumor therapy before infusion, should meet the following any one should be ruled out:
- •treated with systemic corticosteroids therapy within 72 hours (except glucocorticoid physiological replacement therapy, such as prednisone < 10 mg/d or an equivalent dose of the drug);
- •received within 72 hours of small molecule targeted therapy;
- •2 weeks received systemic chemotherapy except (pretreatment);
- •four weeks received radiotherapy;
- •The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
- •Any unsuitable to participate in this trial judged by the investigator;
- •Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.
研究组 & 干预措施
Administration of CD5+ T-ALL Targeted CAR T-cells
Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.
干预措施: CD5 CAR T-cells (Biological)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: Up to 28 days 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
- Overall response rate ,ORR(Up to 12 weeks after CAR-T infusion)
- Duration of remission ,DOR(Up to 1 years after CAR-T infusion)
- Progression Free Survival, PFS(Up to 2 years after Treatment)
- Overall survival, OS(Up to 1 years after CAR-T infusion)
研究者
He Huang
Clinical Professor
Zhejiang University