Actively Recruiting
T Cell Receptor Gene-Engineered T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor
Led by Tao Zhang · Updated on 2025-07-31
9
Participants Needed
2
Research Sites
158 weeks
Total Duration
On this page
Sponsors
T
Tao Zhang
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 18-75 years
- Diagnosis of pathologically or histologically confirmed unresectable or advanced solid tumor with no standard treatment options or unable to tolerate standard treatments
- Positive for HLA-A*11:01
- Tumor has KRAS G12V (for NW-301V cohort) or G12D (for NW-301D cohort) mutation
- Adequate organ function before apheresis and lymphodepleting chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- At least one tumor lesion measurable by RECIST 1.1
You will not qualify if you...
- Received cytotoxic chemotherapy within 2 weeks before apheresis or within 1 week before lymphodepleting chemotherapy
- Received antibody or biologic therapy, including monoclonal antibodies and immune checkpoint inhibitors, within 2 weeks before apheresis or within 1 week before lymphodepleting chemotherapy
- Use of immunosuppressive agents such as calcineurin inhibitors, methotrexate, mycophenolate mofetil, rapamycin, thalidomide, or immunosuppressive antibodies within 2 weeks before apheresis or within 1 week before lymphodepleting chemotherapy
- History of allergic reactions to cyclophosphamide, fludarabine, or any drug components used in the study
- History of chronic or recurrent severe autoimmune disease or active immune disease requiring steroids or immunosuppressants within 1 year prior to enrollment
- Symptomatic central nervous system metastases
- Leptomeningeal disease or carcinomatous meningitis
- Ongoing or active infections
- Active infections with HIV, hepatitis B virus, hepatitis C virus, or syphilis
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Wuhan Union Hospital
Wuhan, Hubei, China, 430022
Actively Recruiting
2
Wuhan Union Hospital
Wuhan, Hubei, 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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