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Clinical Trial NCT06484790 for Tumor, Solid is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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T Cell Receptor Gene-Engineered T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor Phase 1 9 Cell Therapy Open-Label

Recruiting
Clinical Trial NCT06484790 is designed to study Treatment for Tumor, Solid. It is a Phase 1 interventional study that is recruiting, having started on 8 April 2024, with plans to enroll 9 participants. Led by Ting Deng, it is expected to complete by 7 April 2027. The latest data from ClinicalTrials.gov was last updated on 25 November 2025.
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 solid tumor.
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. Eligible subjects will undergo leukapheresis for autologous cell product manufacturing, and will receive a 3-day lymphodepleting regimen consisting of cyclophosphamide and fludarabine, followed by a single-dose intravenous in...Show More
Official Title

An Open-Label, Dose-Escalation Phase I Clinical Study of T Cell Receptor Gene-Engineered T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor

Conditions
Tumor, Solid
Other Study IDs
  • NW-301-001
NCT ID Number
NCT06484790
Start Date (Actual)
2024-04-08
Last Update Posted
2025-11-25
Completion Date (Estimated)
2027-04-07
Enrollment (Estimated)
9
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalNW-301V
NW-301V monotherapy in patients with Solid Tumors with KRAS G12V mutation
NW-301V
TCR-T T cell targeting KRAS G12V mutation
ExperimentalNW-301D
NW-301D monotherapy in patients with Solid Tumors with KRAS G12D mutation
NW-301D
TCR-T T cell targeting KRAS G12D mutation
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Dose-limiting toxicity (DLT)
Safety
28 days of single infusion
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Objective response rate (ORR)
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
through the study completion, with average of 2 years
Duration of response (DOR)
CR and PR, locally assessed using RECIST v1.1
through the study completion, with average of 2 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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.)

  • 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.)
Ting Deng logoTing Deng
Neowise Biotechnology logoNeowise Biotechnology
Study Responsible Party
Ting Deng, Sponsor-Investigator, Director, Tianjin Medical University Cancer Institute and Hospital
Study Central Contact
Contact: Rui Liu, 0512-67991566, [email protected]
Contact: Yuhui He, 0512-67991566, [email protected]
1 Study Locations in 1 Countries

Tianjin Municipality

Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin Municipality, China
Ting Deng, MD, Contact, 022-23340123, [email protected]
Recruiting