Trials / Not Yet Recruiting
Not Yet RecruitingNCT05447234
TCRx_T Cells for Advanced or Recurrent Gastric/Gastroesophageal Junction Cancer After Failure of First Chemotherapy
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
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Tcrx T cell | Sequential IV infusion |
Timeline
- Start date
- 2023-03-01
- Primary completion
- 2026-03-01
- Completion
- 2028-03-01
- First posted
- 2022-07-07
- Last updated
- 2023-02-16
Source: ClinicalTrials.gov record NCT05447234. Inclusion in this directory is not an endorsement.