CART Immunotherapy Targeting CD19 Negative Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Safety of infusion
研究概览
简要总结
This study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 negative ALL that express CD22, CD123, CD38, CD10, CD20 and TSLPR, as many patients developed CD19-negative disease after CD19 CART immunotherapy. Clinical response and development of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.
详细描述
Important Regulatory Notice:
This trial record is only for global academic information registration on ClinicalTrials.gov. Neither the sponsor Beijing Meikang Jimian Biotechnology Co., Ltd. nor collaborator Shenzhen Geno-Immune Medical Institute has obtained NMPA clinical trial approval or clinical technology filing permission to carry out interventional cell therapy trials in mainland China.
ClinicalTrials.gov registration alone does not represent legal approval by Chinese health and drug regulatory authorities.
Anti-CD19 chimeric antigen receptor T cell therapy has demonstrated unprecedented treatment responses in relapsing/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). However, many studies have reported that a subset of patients still relapse and about 30-50% of those relapses are characterized by the loss of CD19 surface antigen. Patients with CD19-negative relapse after CD19 CAR-T-cell therapy usually have a poor prognosis. The mechanisms underlying CD19-negative relapses are not fully understood and it is important to develop solutions to supplement post-CD19 immunotherapies.
Potential markers for recurrent leukemic blasts in an emerging CD19-negative blast population include many known B-cell lineage antigens. To prevent further target escape and improve the therapeutic effects, CAR gene-modified T cells targeting CD22, CD123, CD38, CD10, CD20 or TSLPR have been considered in post CD19 CAR-T immunotherapy. This study aims to evaluate safety and efficacy of administrating one or multiple non-CD19 targeting CAR-T cells to patients with CD19-negative B cell malignancies.
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
- 6 Months 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age older than 6 months.
- •Native CD19 negative B cell malignancies or relapse after CD19-CAR-T immunotherapy.
- •Malignant B cells expressing one or more of the following surface molecules: CD22/CD123/CD38/CD10/CD20/TSLPR.
- •The KPS score over 80 points, and survival time is more than 1 month.
- •Greater than Hgb 80 g/L.
- •No contraindications to blood cell collection.
排除标准
- •Complications with other active diseases, and difficult to assess patient response.
- •Bacteria, fungus, or virus infection, and unable to control.
- •Living with HIV.
- •Active HBV and HCV infection.
- •Pregnant and nursing mothers.
- •Under systemic steroid use within a week of the treatment.
研究组 & 干预措施
4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPR
Patients who have relapsed after CD19 CART immunotherapy or have CD19 negative B cell malignancies
干预措施: 4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPR (Biological)
结局指标
主要结局
Safety of infusion
时间窗: 24 weeks
Treatment-related adverse events are assessed by NCI CTCAE V4.0 criteria.
次要结局
- Anti-tumor activity of CART(1 year)