Tests modified immune T cells against CD276 in solid tumors

Who can take part

• Patients with tumors have received standard first-line therapy and have been judged to be non-resectable, metastatic, progressive or recurrent
• The CD276 antigen status of the tumor is determined for eligibility. Positive expression is defined by antibody staining results based on immunohistochemistry or flow cytometry analysis
• Body weight greater than or equal to 10 kg
• Age: ≥1 year and ≤ 75 years of age at the time of enrollment
• Life expectancy: at least 8 weeks
• Prior Therapy: 1) There is no limit to the number of prior treatment regimens. Any grade 3 or 4 non-hematologic toxicity of any previous therapy must have resolved to grade 2 or less. 2) Must not have received hematopoietic growth factors for at least 1 week prior to mononuclear cells collection. 3) At least 7 days must have elapsed since the completion of therapy with a biologic agent, targeted agent, tyrosine kinase inhibitor or a metronomic nonmyelosuppressive regimen. 4) At least 4 weeks must have elapsed since prior therapy that included a monoclonal antibody. 5) At least 1 week since any radiation therapy at the time of study entry
• Karnofsky/jansky score of 60% or greater
• Cardiac function: Left ventricular ejection fraction greater than or equal to 40/55 percent
• Pulse Ox greater than or equal to 90% on room air
• Liver function: defined as alanine transaminase (ALT) <3x upper limit of normal (ULN), aspartate aminotransferase (AST) <3x ULN; serum bilirubin and alkaline phosphatase <2x ULN
• Renal function: Patients must have serum creatinine less than 3 times upper limit of normal
• Marrow function: White blood cell count ≥1000/ul, Absolute neutrophil count ≥500/ul, Absolute lymphocyte count ≥500/ul, Platelet count ≥25,000/ul (not achieved by transfusion)
• Patients with known bone marrow metastatic disease will be eligible for study as long as they meet hematologic function criteria, and the marrow disease not evaluable to have hematologic toxicity
• For all patients enrolled in this study, themselves or their parents or legal guardians must sign an informed consent and assent

Who cannot take part

• Untreated central nervous system (CNS) metastasis: Patients with CNS tumor involvement that has been treated and/or is stable for at least 6 weeks following completion of therapy are eligible
• Previous treatment with other genetically engineered CD276-CAR T cells or CD276 antibody therapy
• Patients who require systemic corticosteroid or other immunosuppressive therapy
• Existing severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction, or grade 3 hematologic toxicity
• Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection
• Evidence of tumor potentially causing airway obstruction
• Inability to comply with protocol requirements
• Insufficient CAR T cells availability