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

Launched by TINGBO LIANG · Jun 23, 2024

Keywords

ClinConnect Summary

This clinical trial, called NW-301, is exploring a new treatment for patients with advanced solid tumors, specifically those with pancreatic or colorectal cancer that have not responded to standard treatments. The study is testing a type of therapy where the patient's own immune cells are modified to better recognize and attack cancer cells with specific mutations (KRAS G12V or G12D). The main goals of the trial are to see how safe this new treatment is and how well it works.

To be eligible for this trial, participants must be between 18 and 75 years old and have a confirmed diagnosis of pancreatic or colorectal cancer that has not improved with standard treatments. They also need to have a specific genetic marker (HLA-A*11:01) and positive tumor samples for the KRAS mutations. Participants will undergo a procedure to collect their immune cells, which will then be treated and returned to their body. It's important to note that women who can become pregnant and men with female partners need to use effective contraception during the trial. As with any clinical study, participants will receive close monitoring and support throughout the process.

Gender

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.)