Clinical study evaluating the safety and efficacy of WL276 CAR-T cell therapy in CD276 positive recurrent or progressive glioblastoma patients
Diagnosed with glioblastoma through histopathological examination;
Patients with unresectable recurrent or progressive glioblastoma who have failed or are intolerant to standard treatment; 8.1The standardized systematic treatment received by patients must comply with the 2022 edition of the "Guidelines for the Treatment of Gliomas"; 8.2Requirements for treating intolerance: Refers to patients who are unable to continue the current effective systemic standardized treatment due to toxic side effects such as vomiting, diarrhea, abdominal pain, bone marrow suppression, etc. of grade ≥ 3. Refusal due to economic or personal reasons is not accepted;
Age ≥ 18 years old, including boundary values;
Expected survival period greater than 2 months;
Those who require the use of immunosuppressants; Or individuals with autoimmune diseases;
Patients who have received or are waiting for organ transplantation in the past;
The toxicity caused by previous treatment has not stabilized or recovered to ≤ level 1 (except for cases judged by the researcher to be clinically insignificant);
There is a large amount of uncontrollable serosal fluid accumulation (such as pleural effusion, abdominal effusion, pericardial effusion) after treatment;
Sequential
WL276 CAR-T cells
Combination productThis study intends to include 6 subjects, with 3 subjects receiving 5 \* 10 \^ 6 CAR-T Cells and 3 subjects receiving 1 \* 10 \^ 7 CAR-T Cells at different doses
Evaluate the safety（Adverse event incidence rate、Incidence rate of abnormal laboratory test results） and tolerability（DLT incidence rate） of WL276 CAR-T cell therapy for CD276 positive recurrent or progressive glioblastoma
Adverse events related to CAR-T cell therapy within 28 days after infusion, abnormal laboratory test results with clinical significance, including dose limiting toxicity (DLTs).
Progression Free Survival (PFS)
Progression Free Survival (PFS) after infusion.
Overall Survival (OS)
Overall Survival (OS) after infusion.
incidence of adverse events
Collect and compare the safety (incidence of adverse events) of different administration methods
disease improvement rate
Collect and compare the efficacy (disease improvement rate) of different administration methods
CAR-T cell counting
Collect and compare cell expansion data (CAR-T cell counts) after different administration methods
CAR-T cell survival rate
Retention of WL276 CAR-T cells in peripheral blood, cerebrospinal fluid, and/or tumor tissue of patients
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