Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT06043466
Brief 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；
Study:
NCT06043466
Study Brief:
Protocol Section:
NCT06043466