NCT06082570

A Study to Observe and Evaluate the Safety and Efficacy of c610 Injection for Treatment of Advanced Solid Tumor Patients

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	c610 injection	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.

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-03-01
• Completion: 2025-07-01
• First posted: 2023-10-13
• Last updated: 2023-10-13