Actively Recruiting
Study on the Safety and Tolerability of PD-1 Knockout Tumor-infiltrating T Cells (TILs) in the Treatment of Advanced Colorectal Cancer
Led by Ruijin Hospital · Updated on 2025-06-24
29
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study on the Safety and Tolerability of PD-1 Knockout Tumor-infiltrating T Cells (TILs) in the Treatment of Advanced Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with advanced colorectal cancer confirmed by histology or cytology, not eligible for standard treatments at this stage
- Patients willing to undergo surgery or biopsy to obtain tumor tissue for TIL preparation
- Aged 18 to 70 years
- At least one tumor lesion evaluable by RECIST version 1.1
- ECOG performance status of 0 or 1
- Adequate bone marrow and organ function
- Expected survival time of at least 6 months
You will not qualify if you...
- Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, traditional Chinese medicine with anti-tumor effects, or other anti-tumor treatments within 2 weeks before sampling, except nitrosourea or mitomycin C within 6 weeks before surgery, or oral fluorouracils and small molecule targeted drugs within 1 week before surgery
- Received unmarketed investigational drugs within 4 weeks before sampling
- Had major organ surgery (excluding needle biopsy) within 4 weeks before sampling or significant trauma or need for elective surgery during the trial
- Received systemic glucocorticoids (>10 mg/day prednisone or equivalent) or other immunosuppressive therapy within 14 days before sampling (topical, ocular, intra-articular, nasal, inhaled glucocorticoids excluded)
- Used immunomodulatory drugs (e.g., thymosin, interleukin-2, interferon) within 14 days before sampling
- Received live attenuated vaccine within 4 weeks before sampling
- Toxicity from previous cancer therapy not resolved to grade 1 or less per CTCAE 5.0 (except alopecia)
- Symptomatic or uncontrolled central nervous system or leptomeningeal metastases
- Active infection within 1 week before sampling requiring systemic treatment
- History of immunodeficiency including positive HIV test
- Positive for hepatitis B, hepatitis C, or syphilis antibodies
- Current interstitial lung disease
- History of severe cardiovascular or cerebrovascular disease including serious arrhythmias, acute coronary syndrome, heart failure, aortic dissection, stroke within 6 months, NYHA class II or higher, LVEF <50%, or uncontrolled hypertension
- Active or previous autoimmune diseases except stable autoimmune thyroid disease and well-controlled type I diabetes
- Previous immunotherapy with grade 3 or higher immune-related adverse events
- Clinically uncontrollable serous cavity effusion
- Known alcohol or drug dependence
- Mental disorders or poor compliance
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, None Selected, China, 200025
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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