UTAA06 Injection for Treatment of Advanced Malignant Solid Tumors

Inclusion Criteria:

* (1) Age ≥18 years old (including the threshold value), gender is not limited;
* (2) Expected survival time ≥3 months;
* (3) ECOG score 0\~2 points;
* (4) Subjects who meet the clinical diagnostic criteria and are clearly diagnosed as malignant solid tumor by pathology and failed by conventional treatment;
* (5) immunohistochemistry (IHC) staining of tumor tissue samples showed that B7-H3 on tumor cell membrane surface was 1+ or above; while immunohistochemistry (IHC) staining of tumor cell membrane was ≥50%;
* (6) The presence of at least one measurable lesion according to RECIST version 1.1;
* (7) Blood cell analysis (no transfusion treatment within 3 days) : Hemoglobin (Hb) ≥80g/L; Absolute neutrophil count ≥1.5 x 10\^9/L; Platelet count (PLT) ≥75×10\^9/L;
* (8) Kidney, liver, heart and lung function meet the following requirements: Creatinine clearance ≥60 ml/min or serum creatinine ≤ 1.5× upper limit of normal (ULN); Alanine transaminase (ALT) and Aspartate aminotransferase (AST) ≤1.5 x ULN, Total bilirubin (TBL) ≤1.5×ULN (If the elevation of ALT and AST can be reasonably attributed to the presence of metastatic lesions in the liver, AST and ALT can be increased to 5×ULN, TBL can be increased to 3×ULN; Serum albumin ≥3.0g/dL; No clinically significant Electrocardiogram (ECG) results with left ventricular ejection fraction ≥ 50%; Blood oxygen saturation \> 95% in the non-oxygenated state;
* (9) The patient himself/herself and/or his/her guardian and/or impartial witnesses can understand the test and have signed the informed consent.

Exclusion Criteria:

* (1) Patients with continuous use of immunosuppressants within 1 month before infusion of UTAA06 injection;
* (2) cerebrovascular accident or convulsive attack occurred within 6 months before signing the informed consent;
* (3) Hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) positive, and hepatitis B virus (HBV) DNA titer detected by peripheral blood is not within the normal reference value range; Hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive; Human immunodeficiency virus (HIV) antibody positive; EBV DNA test positive; cytomegalovirus (CMV) DNA test positive; Syphilis positive;
* (4) Serious heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe arrhythmia;
* (5) Other unstable systemic diseases as determined by the researcher;
* (6) had other uncured malignant tumors within the past 5 years or at the same time, except for in situ cervical cancer, skin basal cell carcinoma and other in situ cancers;
* (7) Chronic progressive nervous system disease;
* (8) Patients who have not yet recovered from the acute toxic effects of prior treatment (hematological or organ toxicity \> Grade 2 caused by prior treatment, except those related to the studied disease and medical history);
* (9) Previous or current graft-versus-host disease (GVHD);
* (10) There is an active or uncontrolled infection that requires systemic treatment (except for mild genitourinary and upper respiratory tract infections);
* (11) Female subjects who are capable of becoming pregnant and plan to become pregnant within 2 years after the cell infusion; Or a male subject whose partner plans to become pregnant within 2 years of the cell infusion;
* (12) Participating in clinical studies of other innovative drugs within 1 month before screening;
* (13) Evidence of central nervous system invasion during subject screening;
* (14) For patients with liver metastases, the researchers judged that the tumor load of liver metastases was too large to be eligible for inclusion in this clinical trial.
* (15) Situations considered unsuitable for inclusion by other researchers.