NW-301V T-cell therapy for advanced solid tumors with a KRAS G12V mutation
Tests NW-301V cell therapy in adults with advanced KRAS G12V-mutated solid tumors.
Plain-language title generated from the registry record
Registry title: Phase 1 Study of NW-301V TCR-T Cells in Advanced Solid Tumors With KRAS G12V Mutation
Key facts
- Where
- Beijing and Hangzhou, ChinaSee the 2 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 75 with an advanced solid tumor that has a KRAS G12V mutation and who are HLA-A*11:01 positive. Tumor types include pancreatic, colorectal and lung adenocarcinoma.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Advanced or unresectable solid tumor with at least one measurable lesion (RECIST 1.1). In the first part: no standard treatment options available or not able to tolerate them. In the second part: pancreatic ductal adenocarcinoma, colorectal adenocarcinoma or lung adenocarcinoma. Daily activity score (ECOG) of 0-1 and life expectancy over 3 months before leukapheresis.
- Earlier treatment
- Pancreatic cancer and lung adenocarcinoma: at least 1 earlier line of systemic therapy that failed or stopped working. Colorectal cancer: at least 2 earlier lines. In the first part: no standard treatment available or not tolerated.
- Biomarker or test result
- HLA-A*11:01 positive. Tumor confirmed to have the KRAS G12V mutation.
Main reasons for not taking part
- Chemotherapy or immunosuppressive drugs within 2 weeks before leukapheresis, or within 1 week before lymphodepletion
- Antibody or other biologic therapy within 3 weeks before leukapheresis, or within 2 weeks before lymphodepletion
- Allergic reaction to cyclophosphamide, fludarabine or other drug components used in the study
- Severe or recurrent autoimmune disease, or immune disease treated with steroids or immunosuppressants within 1 year
- Symptomatic brain or CNS metastases, leptomeningeal disease, ongoing infection, pregnancy or breastfeeding
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07875920, who can take part
Where in China
- Beijing Cancer HosptialBeijing, ChinaNo longer taking part
- The First Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Neowise Biotechnology
- Trial code
- NCT07875920
- Record updated
- 15 October 2026
- Original description
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.Read full original descriptionShow less
A Single-Arm, Multicenter, Open-Label, Phase Ia/Ib Clinical Study of NW-301V in Advanced Solid Tumors Harboring KRAS G12V Mutations
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.
Inclusion: 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).
Exclusion: 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 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; History of allergic reactions to cyclophosphamide, fludarabine, or any other chemical or biological components of the drugs used in this study; Have leptomeningeal disease or carcinomatous meningitis; Have ongoing or active infection; Applicable to both Phase 1a and 1b:; Have symptomatic CNS metastases; Breastfeeding or pregnant; (Additional protocol-defined Inclusion criteria may apply).