UTAA06 Injection for Treatment of Advanced Malignant Solid Tumors
Summary
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.
Timeline
- Start
- 2023-12-05
- Primary completion
- 2025-05-08
- Completion
- 2025-05-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | UTAA06 | Cell therapy | 1e+08 cells | — |
| Subject | UTAA06 | Cell therapy | 3e+08 cells | — |
| Subject | UTAA06 | Cell therapy | 5e+08 cells | — |
| Subject | UTAA06 | Cell therapy | 8e+08 cells | — |
| Subject | UTAA06 | Cell therapy | 1e+09 cells | — |
Indications
No indication recorded.