DLL3 CAR-T Therapy Targeting Brain Tumors
ConditionGlioblastoma of Cerebellum
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age2-70
SponsorShenzhen Geno-Immune Medical Institute
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- 4SCAR DLL3 T cells
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov