Actively Recruiting
T Cell Receptor Gene-Engineered T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor
Led by Ting Deng · Updated on 2025-11-25
9
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
T
Ting Deng
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...
Key
- Age between 18-75 years
- Diagnosis of pathologically or histologically confirmed unresectable or advanced solid tumor, and have no standard treatment options available or unable to tolerate the currently available standard treatments
- HLA-A11:01positive Tumor has KRAS G12V (NW-301V cohort) or G12D (NW-301D cohort) mutation * Adequate organ function prior to apheresis and lymphodepleting chemotherapy
- ECOG performance status of 0-1
- At least one tumor lesion measurable according to RECIST 1.1 (Additional protocol-defined Inclusion criteria may apply.)
Key
You will not qualify if you...
- Received the following treatments: Cytotoxic chemotherapy within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion; Treatment with antibodies (including but not limited to those with monoclonal antibodies and immune checkpoint inhibitors) or other biologic therapy within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion; Immunosuppressive agents (e.g., calcineurin inhibitors, methotrexate or other chemotherapeutic agents, mycophenolate mofetil, rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti-IL-6, or anti-IL-6 receptor) within 2 weeks prior to apheresis and within 1 week 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 enrollment* Have symptomic CNS metastases
- Have leptomeningeal disease or carcinomatous meningitis
- Have ongoing or active infection
- Active infections with HIV, HBV, HCV, or syphilis
- Breastfeeding or pregnant (Additional protocol-defined Exclusion criteria may apply.)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 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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