Grade 4 Glioma
Conditions
Interventions
Experimental group:Study participants underwent TH-CART-027 cell infusion after a screening period, mononuclear cell collection, and lymphodepletion conditioning period. The initial dose was 6×10^6 ce
Sponsors
Shanghai Tongji Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in the clinical trial; the individual fully understands and is informed of this study and signs the informed consent form; willing to follow and complete all trial procedures. 2. Age >= 18 years old, and = 30%; the positive rate of B7-H3 is defined as: the percentage of B7-H3 positive tumor cells in non-necrotic tumor tissue >= 30%. 5. KPS score >= 60 points or ECOG score 0-1. 6. Sufficient venous access for peripheral blood mononuclear cells (PBMCs) collection is available. 7. One month's echocardiogram shows that the left ventricular ejection fraction (LVEF) >= 40%. 8. At rest, breathing normal air, oxygen saturation >= 95%. 9. Laboratory screening must meet the following standards: a. Hematological function: absolute neutrophil count >= 1.5 × 10^9/L, hemoglobin >= 90g/L, platelet count >= 100 × 10^9/L, absolute lymphocyte count >= 0.15 × 10^9/L. Do not use blood transfusion, granulocyte (macrophage) colony-stimulating factor, recombinant human erythropoietin, recombinant human thrombopoietin, platelet receptor agonists, recombinant human interleukin-11 for supportive treatment within 14 days before testing; b. Liver function: total bilirubin <= 1.5 × ULN, excluding Gilbert's syndrome (patients with persistent or recurrent hyperbilirubinemia without evidence of hemolysis or liver pathology presenting as non-conjugated bilirubin elevation); ALT, AST <= 2.5 × ULN; c. Renal function: serum creatinine <= 1.5 × ULN; d. Coagulation function: in the absence of anticoagulation treatment, prothrombin time (PT), activated partial thromboplastin time (APTT), or international normalized ratio (INR) <= 1.5 × ULN. 10. For pregnant women of childbearing age, urine or serum pregnancy tests must be negative. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test must be conducted. Pregnant women of childbearing age must use highly effective and reliable methods of contraception from the start of the trial until 6 months after the last study treatment; for active men who have not undergone vasectomy, they must agree to use barrier contraception from the start of the trial until 6 months after the last study treatment.
Exclusion criteria
Exclusion criteria: 1. Subjects with severe allergies to any component of the test drug; 2. Pregnant or lactating women; 3. Those with a body weight below 40kg; 4. Viral infections: a. Those with positive serum HIV antibodies or positive serological reactions for Treponema pallidum; b. Those with positive hepatitis B surface antigen (HBsAg) and peripheral blood HBV DNA levels exceeding the upper limit of normal; c. Those with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA; 5. Medical history and accompanying diseases: a. Those who have undergone carbostatin sustained-release agent implant surgery within 6 months; b. Those with known or suspected active autoimmune diseases, including but not limited to Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, etc.; c. Those who are receiving systemic immunosuppressants or those whose treatment period is judged by the investigator to require long-term use of immunosuppressants, except for intermittent topical, inhalation or nasal use of glucocorticoids; d. Those with uncontrollable mental disorders, or those with medical histories or mental state histories that may increase the risks associated with participating in the study or administration of the study drug, or may interfere with the results; e. Those with toxic and side effects caused by previous treatment that have not recovered to CTCAE V5.0 grade evaluation <= 1; excluding hair loss and other events judged by the investigator to be tolerable; f. Those who have participated in other interventional clinical studies within the past 1 month; g. Those who have received CAR-T therapy or other gene therapy; h. Any serious or poorly controlled diseases that may increase the risks associated with participating in the study or the administration of the study drug, or may affect the ability of the subject to receive the study drug, including but not limited to cardiovascular and cerebrovascular diseases, renal insufficiency, pulmonary embolism, coagulation dysfunction or long-term anticoagulation treatment, active infections or uncontrollable infections that require systemic treatment; i. Those who have had other malignant tumors within the past 3 years, excluding non-melanoma skin cancer, carcinoma in situ (such as cervix, bladder, breast), etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: maximum tolerated dose and dose toxicity;Safety: incidence and severity of adverse events (AEs); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate;Progression-Free Survival;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactChun Luo
Shanghai Tongji Hospital
Outcome results
None listed