Phase 1 Study of NW-301V TCR-T Cells in Advanced Solid Tumors With KRAS G12V Mutation

This is a single-arm, multicenter, open-label, Phase 1a/1b dose-escalation and dose-expansion study designed to evaluate the safety, preliminary antitumor activity, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of NW-301V, an autologous TCR-T cell therapy, in Chinese adult participants with advanced malignant solid tumors harboring a KRAS G12V mutation.

Key Inclusion Criteria: Applicable to both Phase 1a and 1b: * Age between 18-75 years * HLA-A\*11:01 positive * Tumor confirmed to have KRAS G12V mutation * At least one measurable lesion according to RECIST 1.1 * ECOG 0-1 * Life expectancy \> 3 months before leukapheresis * Adequate organ functions prior to leukapheresis and lymphodepletion For Phase 1a only: * Histologically or pathologically confirmed, advanced or unresectable solid tumors including, but not limited to, pancreatic ductal adenocarcinoma (PDAC), colorectal adenocarcinoma (CRC), and lung adenocarcinoma (LUAD) * Participants must have no standard treatment options available or are unable to tolerate currently available standard treatment For Phase 1b only: * Cohort A: Histologically or pathologically confirmed advanced or locally advanced unresectable PDAC that had failed or progressed after at least 1 line of prior systemic therapy * Cohort B: Histologically or pathologically confirmed advanced CRC that had failed or progressed after at least 2 lines of prior systemic therapies * Cohort C: Histologically or pathologically confirmed advanced LUAD that had failed or progressed after at least 1 line of prior systemic therapy (Additional protocol-defined Inclusion criteria may apply) Key Exclusion Criteria: Applicable to both Phase 1a and 1b: * Received the following treatments: Cytotoxic chemotherapy or immunosuppressive agents within 2 weeks prior to leukapheresis, or within 1 week prior to lymphodepletion; Antibodies or other biologic therapy within 3 weeks prior to leukapheresis, or within 2 weeks 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 leukapheresis or lymphodepletion * Have symptomatic CNS metastases * Have leptomeningeal disease or carcinomatous meningitis * Have ongoing or active infection * Breastfeeding or pregnant (Additional protocol-defined Inclusion criteria may apply)