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.
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. This study aims to evaluate the safety, feasibility, and preliminary efficacy of DLL3-directed CAR-T cells in patients with recurrent or refractory brain tumors. These studies represent a critical step toward harnessing the immune system to fight traditionally treatment-resistant cancers, offering new hope for patients with few other options.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Infusion of 4SCAR DLL3 T cells at 10\^6 cells/kg body weight via intravenous route
Shenzhen Geno-immuno Medical Institute
Shenzhen, Guangdong, China
RECRUITINGNumber of patients with adverse events.
Determine the toxicity profile the 4SCAR DLL3 cells with Common Toxicity Criteria for Adverse Effects version 4.0
Time frame: 6 months
Anti-tumor effects
Objective responses (complete response (CR) are assessed by the Response Evaluation Criteria in Glioblastoma (RECIST) v1.1 criteria.
Time frame: 1 year
Anti-tumor effects
Objective responses partial response (PR)) are assessed by the Response Evaluation Criteria in Glioblastoma (RECIST) v1.1 criteria.
Time frame: 1 year
The expansion of 4SCAR DLL3 T cells
Scale of CAR copies for efficacy
Time frame: 1 year
The persistence of 4SCAR DLL3 T cells
Scale of tumor burden for efficacy
Time frame: 1 year
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