Status:
RECRUITING
T Cell Receptor Gene-Engineered T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor
Lead Sponsor:
Ting Deng
Collaborating Sponsors:
Neowise Biotechnology
Conditions:
Tumor, Solid
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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 soli...
Detailed Description
Using a modified 3+3 dose escalation design, this study will enroll \~9subjects to characterize the safety and preliminary anti-tumor activity of NW-301V and NW-301D in each cohort respectively. Eligi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.)
Key Trial Info
Start Date :
April 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 7 2027
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT06484790
Start Date
April 8 2024
End Date
April 7 2027
Last Update
November 25 2025
Active Locations (1)
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1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China