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:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT05447234
Brief Summary:
To observe and determine the safety, tolerability, cellular pharmacokinetics and efficacy of TCRx T cells in patients with advanced or recurrent gastric/gastroesophageal junction cancer after failure of first chemotherapy.
Detailed Description:
1. Sign the informed consent for clinical trials
2. Subject screening
3. Extract the blood of the subjects and isolate the PBMC
4. Find a patient-specific tumor-specific TCR sequence combination, which is a multi-targeted tumor-specific combination.
5. Transfer of personalized tumor-specific TCRs into patient autologous CD8 T cells by gene editing
6. Large-scale culture and expansion of gene-edited T cells
7. T cell viability, infection efficiency and microbial detection in hospital
8. Calculate the number of cells in the patient's body according to TCRx T
9. Injecting TCRx T cells back into the subject
10. Within 7 days after the injection, the subject's post-dose reaction should be closely observed in the hospital
11. After the first injection, continue to reinfuse TCRx T cells up to 4 times according to the treatment effect and the incidence of adverse events, and be hospitalized after each injection to closely monitor possible adverse events
Study:
NCT05447234
Study Brief:
Protocol Section:
NCT05447234