Actively Recruiting
T Cell Receptor Gene-Engineered T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor
Led by TingBo Liang · Updated on 2025-11-25
9
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
Sponsors
T
TingBo Liang
Lead Sponsor
N
Neowise Biotechnology
Collaborating Sponsor
AI-Summary
What this Trial Is About
An open label, two-cohort, dose-escalation clinical study to evaluate the safety, anti-tumor activity and pharmacokinetics/pharmacodynamic (PK/PD) of NW-301V and NW-301D in subjects with advanced solid tumor.
CONDITIONS
Official Title
T Cell Receptor Gene-Engineered T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Diagnosed with unresectable or advanced solid tumor with no standard treatment options or unable to tolerate standard treatments
- HLA-A*11:01 positive
- Tumor has KRAS G12V mutation for NW-301V or G12D mutation for NW-301D cohort
- Adequate organ function before cell collection and lymphodepleting chemotherapy
- ECOG performance status of 0 or 1
- At least one measurable tumor lesion according to RECIST 1.1
You will not qualify if you...
- Received cytotoxic chemotherapy within 2 weeks before cell collection or within 1 week before lymphodepleting chemotherapy
- Received antibody or other biologic therapy within 2 weeks before cell collection or within 1 week before lymphodepleting chemotherapy
- Received immunosuppressive agents within 2 weeks before cell collection or within 1 week before lymphodepleting chemotherapy
- History of allergic reactions to cyclophosphamide, fludarabine, or other study drugs
- History of chronic or recurrent severe autoimmune disease or active immune disease needing steroids or immunosuppressants within 1 year
- Symptomatic central nervous system metastases
- Leptomeningeal disease or carcinomatous meningitis
- Ongoing or active infection
- Active infections with HIV, HBV, HCV, or syphilis
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhejiang University school of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
R
Rui Liu
CONTACT
Y
Yuhui He
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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