OncoMatch/Clinical Trials/NCT07035002
Study on the Safety and Tolerability of PD-1 Knockout Tumor-infiltrating T Cells (TILs) in the Treatment of Advanced Colorectal Cancer
Is NCT07035002 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including transfusion of 5×10^8 PD-1 knockout TILs per kg body weight and transfusion of 1×10^9 PD-1 edited TILs per kg body weight for colorectal cancer (crc).
Treatment: 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 — 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 cells, leading to T cell enrichment within the tumor. However, due to the immunosuppressive effect of tumors through various ways, the enriched T cells in tumors cannot effectively kill tumor cells. One of the most common examples is that tumors up-regulate the expression of immune checkpoint protein PD-L1, which binds to PD-1 on the surface of T cells and inhibits T cell function. Therefore, in this study, we will obtain tumor tissue via surgery resection or biopsy, and then isolate TIL cells in the tumor under GMP conditions, and further use gene editing technology to knockout PD-1, the obtained gene-edited T cells will have the characteristics of specific recognition of tumor cells, but not sensitive to the immunosuppressive function of tumor cells, so as to achieve the therapeutic effect on tumor patients.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Metastatic disease required
advanced colorectal cancer...At least one tumor lesion that could be evaluated according to RECIST, version 1.1.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Exception: nitrosourea or mitomycin C within 6 weeks before surgery; oral fluorouracils and small molecule targeted drugs for 1 week before surgery
Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, traditional Chinese medicine with anti-tumor indications and other anti-tumor treatments within 2 weeks before sampling, except the following: 1. Nitrosourea or mitomycin C within 6 weeks before surgery; 2. Oral fluorouracils and small molecule targeted drugs for 1 week before surgery.
Cannot have received: radiotherapy
Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, traditional Chinese medicine with anti-tumor indications and other anti-tumor treatments within 2 weeks before sampling
Cannot have received: biological therapy
Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, traditional Chinese medicine with anti-tumor indications and other anti-tumor treatments within 2 weeks before sampling
Cannot have received: endocrine therapy
Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, traditional Chinese medicine with anti-tumor indications and other anti-tumor treatments within 2 weeks before sampling
Cannot have received: immunotherapy
Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, traditional Chinese medicine with anti-tumor indications and other anti-tumor treatments within 2 weeks before sampling
Cannot have received: traditional Chinese medicine with anti-tumor indications
Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, traditional Chinese medicine with anti-tumor indications and other anti-tumor treatments within 2 weeks before sampling
Cannot have received: investigational drug or treatment
Received other unmarketed investigational drug or treatment within 4 weeks before sampling
Lab requirements
Blood counts
adequate bone marrow
Kidney function
adequate organ function
Liver function
adequate organ function
Adequate bone marrow and organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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