Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07474168
Eligibility Criteria:
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.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07474168
Study Brief:
Protocol Section:
NCT07474168