NCT07875920Not yet recruitingPhase 1
Phase 1 Study of NW-301V TCR-T Cells in Advanced Solid Tumors With KRAS G12V Mutation
A Single-Arm, Multicenter, Open-Label, Phase Ia/Ib Clinical Study of NW-301V in Advanced Solid Tumors Harboring KRAS G12V Mutations
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 30 Sept 2026
- Start date
- Oct 2026
- Primary completion date
- Mar 2030
- Lead sponsor
- Neowise Biotechnology
- Diseases
- Lung cancer, Pancreatic cancer, Colorectal cancer
- NCT number
- NCT07875920
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 66
- From Oct 2026 to the primary completion date, Mar 2030
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Applicable to both Phase 1a and 1b:
- Have symptomatic CNS metastases
- Breastfeeding or pregnant
- (Additional protocol-defined Inclusion criteria may apply)
Who the study is looking for
- 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)
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Cancer Hosptial Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.