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NCT07474168phase 1active not recruiting
T Cell Receptor Gene-Engineered and Dominant Negative TGF-β Receptor T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor
9
Enrollment · estimated
1
Countries · 1 sites
2027-02
Primary completion
5 mo ago
Record updated
Commercial relevance
Trial record references molecular eligibility required.
Molecular eligibility required
Change timeline
Signals from this trial
- New trial52/100Opportunity
New phase 1 trial NCT07474168 posted by Zhejiang University: "T Cell Receptor Gene-Engineered and Dominant Negative TGF-β Receptor T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor".
Eligibility — raw, for validation
Inclusion Criteria: * Age between 18-75 years * Diagnosis of pathologically or histologically confirmed unresectable or advanced solid tumor, and have no standard treatment options available or unable to tolerate the currently available standard treatments * HLA-A\*11:01positive * Tumor has KRAS G12V mutation * Adequate organ function prior to apheresis and lymphodepleting chemotherapy * ECOG performance status of 0-1 * At least one tumor lesion measurable according to RECIST 1.1 (Additional protocol-defined Inclusion criteria may apply.) Key Exclusion Criteria: * Received the following treatments: Cytotoxic chemotherapy within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion; Treatment with antibodies (including but not limited to those with monoclonal antibodies and immune checkpoint inhibitors) or other biologic therapy within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion; Immunosuppressive agents (e.g., calcineurin inhibitors, methotrexate or other chemotherapeutic agents, mycophenolate mofetil, rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti-IL-6, or anti-IL-6 receptor) within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion * History of allergic reactions to cyclophosphamide, fludarabine, or any other chemical or biological components of the drugs used in this study * History of chronic or recurrent severe autoimmune disease, or active immune disease requiring treatment with steroids or other immunosuppressive agents within 1 year prior to enrollment * Have symptomic CNS metastases * Have leptomeningeal disease or carcinomatous meningitis * Have ongoing or active infection * Active infections with HIV, HBV, HCV, CMV or syphilis * Breastfeeding or pregnant (Additional protocol-defined Exclusion criteria may apply.)