Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 5:06 PM
Study NCT ID:
NCT05447234
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-16
First Post:
2022-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TCRx_T Cells for Advanced or Recurrent Gastric/Gastroesophageal Junction Cancer After Failure of First Chemotherapy
Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Organization:
Study Overview
Official Title:
Exploratory Clinical Study of TCRx_T Cells in the Treatment of Advanced or Recurrent Gastric/Gastroesophageal Junction Cancer After Failure of First Chemotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: