nctId: NCT06372236 id: PG-001-025 briefTitle: UTAA06 Injection for Treatment of Advanced Malignant Solid Tumors overallStatus: RECRUITING date: 2023-12-01 date: 2024-12-01 date: 2026-12-01 date: 2024-04-17 date: 2024-04-17 name: Peking University class: OTHER briefSummary: This is a single-arm, open, early-stage clinical study. The main purpose of this study is to explore the maximum tolerated dose (MTD), the optimal phase II recommended dose, safety, initial anti-tumor activity, cytopharmacokinetics, immunogenicity, biomarkers and other characteristics of drug therapy in patients with advanced malignant solid tumors. Eligible subjects were transfused with UTAA06 injection after pretreatment, and their blood was collected before and after infusion for evaluation of cytopharmacokinetics, safety, immunogenicity and biomarkers. In this study, tumor evaluation was mainly performed using RECISTv1.1. In addition to the baseline period, the therapeutic efficacy was evaluated at the frequency of Q3m during 4w, 2m, 3m, and 6-24m after cell infusion. Tumor evaluation was performed until disease progression (PD), new anti-tumor therapy, death, intolerable toxicity, investigator's decision, or patient's voluntary withdrawal. Whichever comes first. conditions: Conditions or Focus of Study: B7-H3 Positive Relapsed/Advanced Malignant Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: UTAA06 injection primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: UTAA06 injection for treatment of advanced malignant solid tumors measure: MTD measure: To evaluate the preliminary antitumor activity of UTAA06 injection in patients with advanced malignant solid tumors measure: To evaluate the number of participants with treatment-related adverse events of UTAA06 injection in patients with advanced malignant solidtumors. measure: To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors. measure: To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors. measure: To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors. measure: To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors. measure: To evaluate the pharmacokinetic (PK) characteristics of UTAA06 injection in patients with advanced malignant solid tumors. measure: To evaluate the pharmacokinetic (PK) characteristics of UTAA06 injection in patients with advanced malignant solid tumors. measure: To evaluate the immunogenicity of UTAA06 injection in patients with advanced malignant solid tumors. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PersonGen Anke Cellular Therapeutice Co.,Ltd status: RECRUITING city: Hefei state: Anhui zip: 230088 country: China name: Huimin Meng, Doctor role: CONTACT phone: +86-18015580390 email: huimin.meng@persongen.com lat: 31.86389 lon: 117.28083 hasResults: False