Advanced Solid Tumors Clinical Trial
Official title:
A Clinical Study on the Observation and Evaluation on the Safety and Efficacy of c610 Injection in the Treatment of Patients With Advanced Solid Tumors
This is an open-labeled, single-arm, multiple-dose escalation and single-dose expansion clinical study of cell therapy to observe and evaluate the safety and efficacy of c610 injection in the treatment of patients with advanced solid tumors.
Primary Objection: 1. The mainly purpose of dose-escalation stage is to observe and evaluate the safety and tolerability of c610 injection in patients with advanced solid tumor, including the dose-limited toxicity(DLT) and the maximum tolerated dose (MTD). 2. The mainly purpose of dose-expansion stage is to evaluate the safety and efficacy of c610 injection in the treatment of patients with advanced solid tumors. 3. To evaluate the objective remission rate (ORR) and disease control rate (DCR) of 3 months according by the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) Secondary Objection: 1. To observe the pharmacokinetic (PK) characteristics of c610 injection in patients with advanced solid tumors and its retention in peripheral blood; 2. To evaluate the progression free survival (PFS), overall objective response rate (ORR), duration of response (DOR), and overall survival (OS) according by the Response Evaluation Criteria In Solid Tumors (RECIST 1.1); 3. To observe the change in cytokines release before and after c610 injection treatment; 4. To observe the variation of tumor biomarker before and after c610 injection treatment (e.g. prostate cancer serum PSA). Exploratory objection: To investigate the potential biological indicators of blood and tumor specimen, including ctDNA (circulating tumor DNA) sequencing, immune repertoire sequencing (tumor tissue is prior for single-cell sequencing), ADA and RCL detection. ;
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