T Cell Receptor Gene-Engineered T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor

Launched by TAO ZHANG · Jun 26, 2024

Keywords

ClinConnect Summary

This clinical trial, called NW-301, is investigating a new treatment for patients with advanced solid tumors, specifically those with certain types of cancer that have a specific gene mutation known as KRAS G12V or G12D. The study is looking to understand how safe and effective this treatment is, as well as how it behaves in the body. It is currently open for enrollment, and participants can be men or women aged 18 to 75 who have been diagnosed with pancreatic cancer, colorectal cancer, or lung adenocarcinoma and have not responded to or cannot tolerate standard treatments.

To participate, individuals will need to have a measurable tumor and specific genetic markers in their tumor tissue. Participants can expect to undergo a procedure to collect their own immune cells, which will be treated and given back to them as part of the treatment. It's important for potential participants to know that there are specific health criteria they must meet, and certain recent treatments or health conditions may exclude them from the trial. Overall, this study aims to evaluate a promising new approach to treating challenging cancers.

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ALL

Eligibility criteria

• Key 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 (NW-301V cohort) or G12D (NW-301D cohort) 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, or syphilis
• • Breastfeeding or pregnant
• • (Additional protocol-defined Exclusion criteria may apply.)