Conditions or Focus of Study: B7-H3 Positive Relapsed/Advanced Malignant Solid Tumor Clinical Trial
Official title:
Phase I Clinical Study of UTAA06 Injection in Treatment of Patients With Advanced Malignant Solid Tumors
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.
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. This research mainly adopts RECISTv1.1 tumor assessment, in addition to the baseline period, treatment period after the cell infusion, 2 m, 3 m, 4 w during 6 to 24 m in the frequency of Q3m curative effect evaluation of tumor assessment until disease progression (PD, Other than spurious progression), new anti-tumor therapy, death, intolerable toxicity, investigator decision, or patient voluntary withdrawal, whichever occurs first. In this study phase, the recommended dose is 1×10^8~1×10^9CAR+gdT (including 1×10^8CAR+gdT, 3×10^8CAR+gdT, 5×10^8CAR+gdT, 8×10^8CAR+gdT, 1×10^9CAR+gdT), or as determined by the investigator and/or partner unit. Other doses can be added. Each subject in the same dose group can receive the infusion of the next subject after 14 days of observation, and the last subject in each dose group can be observed for 28 days after infusion, and the researcher will determine whether the treatment can be incremented into the next dose group based on safety detection indicators. A total of 15 to 24 patients with advanced malignant solid tumors were enrolled. B7-H3 is a pan-tumor antigen that is overexpressed on a variety of solid tumors. This study is a B7-H3 targeted therapy, and it is planned to conduct a pan-tumor study without targeting specific tumor species, and does not consider classification and dose allocation according to tumor species. ;