Status:
RECRUITING
DLL3 CAR-T Therapy Targeting Brain Tumors
Lead Sponsor:
Shenzhen Geno-Immune Medical Institute
Conditions:
Glioblastoma of Cerebellum
Eligibility:
All Genders
2-70 years
Phase:
PHASE1
PHASE2
Brief 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 glioblastoma...
Detailed Description
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 lev...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2029
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07180927
Start Date
September 10 2025
End Date
September 30 2029
Last Update
September 18 2025
Active Locations (1)
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1
Shenzhen Geno-immuno Medical Institute
Shenzhen, Guangdong, China, 518000