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

Launched by TING DENG · Jun 26, 2024

Keywords

ClinConnect Summary

This clinical trial, called NW-301, is exploring a new treatment using specially modified immune cells to help patients with advanced solid tumors, such as pancreatic, colorectal, or lung cancer. The treatment focuses on patients whose tumors have specific changes in their genes known as KRAS G12V or G12D mutations. The trial is currently looking for participants aged 18 to 75 who have already tried standard treatments without success or could not tolerate them. To join, participants need to have a measurable tumor and certain health conditions, such as having sufficient function of their organs.

If you participate in this trial, you can expect to receive the experimental treatment in a safe environment, with medical staff closely monitoring your health throughout the study. It's important to note that there are specific requirements for participating, including avoiding certain medications before the trial. Additionally, both male and female participants need to follow guidelines regarding contraception to prevent pregnancy during the study. This trial aims to evaluate how safe and effective this treatment is, which could potentially lead to new options for patients facing advanced cancer.

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-A11:01positive 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.)