4sCAR-DLL3 CAR-T Therapy Targeting Brain Tumors
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of patients with adverse events.
研究概览
简要总结
The purpose of this study is to assess the feasibility, safety and efficacy of Delta-like ligand 3 (DLL3)-specific CAR-T cell therapy in patients with DLL3 positive brain tumors including glioblastomas and diffused intrinsic pontine or midline gliomas (DIPG or DMG). Another goal of the study is to learn more about the function of the anti-DLL3 CAR-T cells and their persistency in patients.
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.
Glioblastoma (GBM) and other aggressive brain tumors remain among the most challenging cancers to treat, with limited therapeutic options and poor survival rates. GBM is known to express increased levels of certain antigens that can be targeted by T cells including chimeric antigen receptor-modified T (CAR-T) cells.
One promising target in this effort is DLL3, a protein highly expressed on the surface of certain tumor cells including GBM/DIPG/DMG and other central nervous system malignancies but with minimal presence in normal tissues. This expression pattern makes DLL3 an attractive target for precision CAR-T therapy treating brain tumors, which involves engineering a patient's own T cells to recognize and eliminate cancer cells expressing this specific marker.
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
- 2 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •abilities to understand and the willingness to provide written informed consent;
- •patients are ≥ 2 and ≤ 70 years old;
- •recurrent or refractory brain tumor patients with measurable lesions. Patients have received standard care of medication, such as gross total resection with concurrent radio-chemotherapy (~54 - 60 Gy, TMZ). Patients must either not be receiving dexamethasone or receiving ≤ 4 mg/day at the time of leukopheresis;
- •Karnofsky performance score (KPS) ≥ 60;
- •life expectancy >3 months;
- •satisfactory bone marrow, liver and kidney functions as defined by the following: absolute neutrophile count ≥ 1500/mm^3; hemoglobin > 10 g/dL; platelets > 100000 /mm^3; Bilirubin < 1.5×ULN; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5×ULN; creatinine < 1.5×ULN;
- •peripheral blood absolute lymphocyte count must be above 0.8×10^9/L;
- •satisfactory heart functions;
- •patients must be willing to follow the instructions of doctors;
- •women of reproductive potential (between 15 and 49 years old) must have a negative pregnancy test within 7 days of study start. Male and female patients of reproductive potential must agree to use birth control during the study and 3 months post study.
排除标准
- •a prior history of gliadel implantation 4 weeks before this study start or currently receiving antibody based therapies;
- •HIV positive;
- •tuberculosis infection not under control;
- •history of autoimmune disease, or other diseases require long-term administration of steroids or immunosuppressive therapies;
- •history of allergic disease, or allergy to immune cells or study product excipients;
- •patients already actively enrolled in other immune cell clinical study; patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
研究组 & 干预措施
4SCAR-DLL3 T Cell Therapy treating DLL3 positive glioblastoma
Infusion of 4SCAR-DLL3 T cells at 10^6 cells/kg body weight via intravenous route
干预措施: 4SCAR DLL3 T cells (Biological)
结局指标
主要结局
Number of patients with adverse events.
时间窗: 6 months
Determine the toxicity profile the 4SCAR DLL3 cells with Common Toxicity Criteria for Adverse Effects version 4.0
Number of patients with adverse events.
时间窗: 6 months
Determine the toxicity profile the 4SCAR DLL3 cells with Common Toxicity Criteria for Adverse Effects version 4.0
次要结局
- Anti-tumor effects(1 year)
- The expansion of 4SCAR DLL3 T cells(1 year)
- The persistence of 4SCAR DLL3 T cells(1 year)
- Anti-tumor effects(1 year)
- The expansion of 4SCAR DLL3 T cells(1 year)
- The persistence of 4SCAR DLL3 T cells(1 year)