RecruitingPhase 1Phase 2NCT07180927
DLL3 CAR-T Therapy Targeting Brain Tumors
4sCAR-DLL3 CAR-T Therapy Targeting Brain Tumors
Sponsor
Shenzhen Geno-Immune Medical Institute
Enrollment
30 participants
Start Date
Sep 10, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 2 YearsMax Age: 70 Years
Inclusion Criteria10
- 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.
Exclusion Criteria6
- 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.
Interventions
BIOLOGICAL4SCAR DLL3 T cells
Infusion of 4SCAR DLL3 T cells at 10\^6 cells/kg body weight via intravenous route
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07180927