Clinical trial · Interventional
T Cell Receptor Gene-Engineered and Dominant Negative TGF-β Receptor T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor
An Open-Label, Dose-Escalation Phase I Clinical Study of T Cell Receptor Gene-Engineered and Dominant Negative TGF-β Receptor T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor
NCT07474168CI-TRIAL-00105544active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
An open label, dose-escalation clinical study to evaluate the safety, anti-tumor activity and pharmacokinetics/pharmacodynamic (PK/PD) of NW-301VT in subjects with advanced solid tumor.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NW-301VT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NW-301VT monotherapy in patients with Solid Tumors with KRAS G12V mutation
- interventionNames
- Drug: NW-301VT
Primary outcomes (1)
- measure
- Dose-limiting toxicity (DLT)
- timeFrame
- 28 days following NW-301VT infusion
- description
- Safety
Secondary outcomes (2)
- measure
- Objective response rate (ORR)
- timeFrame
- Through study completion, an average of 2 years
- description
- complete response (CR) and partial response (PR) based on best overall response (BOR), locally assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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-A\*11:01positive * Tumor has KRAS G12V 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 Criteria: * 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, CMV or syphilis * Breastfeeding or pregnant (Additional protocol-defined Exclusion criteria may apply.)
References
Publications (0)
Data not yet available
No reference posted for this study.