NCT06043466

A Clinical Trial Targeting CEA Chimeric Antigen Receptor T (CAR-T) for CEA Positive Advanced Malignant Solid Tumors

Phase I Clinical Study of Chimeric Antigen Receptor T Cells (C-13-60) in the Treatment of Carcinoembryonic Antigen (CEA) Positive Advanced Malignant Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Chongqing Precision Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open, dose-increasing phase I clinical study to explore the safety, tolerability and pharmacokinetic characteristics of the drug C-13-60 cells, and preliminarily observe the efficacy of the drug in CEA positive late malignant solid tumors, and explore the applicable dose regimen for phase II clinical trials.

Detailed description

According to the sequence principle of low and high dose of C-13-60 cell reinfusion, the dose escalation experiment was carried out successively. Three subjects in each dose group were enrolled first. If DLT did not appear, the decision of whether to enter the next dose group was made according to Safety review committee (SRC) resolution. If there was one case of DLT, then 3 subjects were enrolled one by one, and DLT observation was completed for 28 days after each subject's infusion. If no DLT was found, the next infusion was continued. If DLT was found, the subsequent enrollment of the dose group was terminated, and the experiment was terminated or the dose was reduced according to the dose increasing principle. If \> 1 case of DLT occurs, the trial is terminated or the dose is reduced.According to the evaluation of the researchers, the subjects who met the conditions of antisepsis received antisepsis chemotherapy 1-5 to -3 days before the transfusion of C-13-60 cells；

Conditions

• Colorectal Cancer
• Esophagus Cancer
• Gastric Cancer
• Pancreas Cancer
• Non-small Cell Lung Cancer
• Breast Cancer
• Bile Duct Cancer

Interventions

Type	Name	Description
BIOLOGICAL	CEA-targeted CAR-T cells	Administration method: intravenous infusion； Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.

Timeline

• Start date: 2023-08-11
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2023-09-21
• Last updated: 2023-09-21

Locations

2 sites across 1 country: China