Study on the Safety and Tolerability of PD-1 Knockout Tumor-infiltrating T Cells (TILs) in the Treatment of Advanced Colorectal Cancer

TIL from tumor tissue of advanced colorectal cancer patients were cultured, modified and expanded in vitro, and then transfused back to the patients after quality control. The safety and efficacy of the treatment were investigated. The fundamental cause of oncogenesis lies in the accumulation of gene mutations. A large number of gene mutations in tumor cells lead to changes in the encoded amino acid sequence, resulting in the production of tumor-specific proteins. Human T cells recognize tumor-specific peptides (tumor neoantigens) that are presented on the MHC molecules on the surface of tumor

Trial Details

NCT ID
NCT07035002
Phase
PHASE1
Sponsor
Ruijin Hospital
Status
RECRUITING
Cancer Type
Colon Cancer Colorectal Cancer
Interventions
  • transfusion of 5×10^8 PD-1 knockout TILs per kg body weight
  • transfusion of 1×10^9 PD-1 edited TILs per kg body weight
  • transfusion of 2×10^9 PD-1 edited TILs per kg body weight
  • transfusion of maximum dose without side effects among group A, B and C
Locations (sample)
  • Shanghai, None Selected, China|31.22222,121.45806

Key Eligibility Criteria

  • Patients with advanced colorectal cancer confirmed by histology or cytology, who were not eligible to standard treatment at this stage.
  • Patients volunteered to receive surgery or biopsy to obtain tumor tissue for TILs preparation.
  • Aged ≥18 and ≤70 years old.
  • At least one tumor lesion that could be evaluated according to RECIST, version 1.1.

For full eligibility, visit ClinicalTrials.gov.

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