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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Peripheral blood mononuclear cells (PBMCs) are used for cell preparation. PD-1 positive T cells are isolated from peripheral blood by blood cell apheresis method and transduced with lentivirus loaded with enhanced receptors. The obtained c610 is used for one-time intravenous infusion.
Objective Response Rate(ORR)
The number of cases with CR (complete remission) and PR (partial remission) accounted for the total number of evaluable cases.
Time frame: 3 months after c610 transfusion
Disease Control Rate(DCR)
The number of cases with remission and stable lesions after treatment accounted for the total number of evaluable cases.
Time frame: 3 months after c610 transfusion
Progression-Free Survival(PFS)
A time quantum from the day which subject received c610 transfusion to the day which subject was evaluated of the first disease progression or death due to any reasons.
Time frame: From the day of c610 transfusion until the day of first documented progression or death from any cause, whichever came first, assessed up to 27 months.
Objective Response Rate(ORR)
The number of cases with remission and stable lesions after treatment accounted for the total number of evaluable cases.
Time frame: through study completion, an average of 27 months.
Duration of Response(DOR)
A time quantum from the day which subject first evaluated as CR or PR to the day which subject was evaluated as PD or death due to any reasons.
Time frame: From the day that the subject was first evaluated as CR or PR to the day which subject was evaluated as PD or death due to any reasons, assessed up to 27 months.
Overall Survival (OS)
A time quantum from the day subject received c610 transfusion to death due to disease.
Time frame: From the day of T60c transfusion until the day of c610 transfusion to death due to disease, assessed up to 27 months.
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